Immunogen: Mirvetuximab soravtansine ein zukünftiger Blockbuster (Seite 14)
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Antwort auf Beitrag Nr.: 54.972.299 von Joschka Schröder am 18.05.17 16:12:24Sei doch nicht so pessimistisch... Ich muss gestehen, dass ich das Unternehmen nicht sonderlich gut kenne. Aber wenn man auf deren Homepage geht, die Pipeline aufruft und diese nicht auf eine Seite passt, dann ist das für mich schon mal ein Argument die Firma etwas genauer zu betrachten und auch zu investieren. Zumindest bei der MC.
Mir ist die aktuelle Euphorie etwas rätselhaft (welche Erwartungen hatte die Investmentgemeinde zuvor?), weshalb ich mit steigenden Kursen (bis 5,42 USD) weiter IMGN-Aktien verkauft habe.
Die Mono-Daten untermauern die bislang bekannten Studienergebnisse. In gewisser Weise stellen sie für den Investoren eine zusätzliche Absicherung dar, bieten ansonsten aber nichts Neues.
Die Kombi-Daten sind nicht leicht interpretierbar:
Die Avastin-Kombi-Daten sehen zunächst einmal sehr schwach aus, einschränkend muss man jedoch bemerken, dass die Patienten wirklich stark vorbehandelt waren. Unklar ist, in welchem Ausmaß das Patientenkollektiv Platinum-sensitiv bzw. -resistent war. Insgesamt sind die Daten wohl eher negativ zu bewerten.
Die Ergebnisse der Carboplatin-Kombi bei sensitiven Patienten entspricht etwa dem, was auch mit anderen Kombi-Therapien erreicht wird.
Über die Keytruda-Kombidaten wird nicht berichtet. Begründet wird dies mit der unreifen Datenlage. Da bereits für die Expansionskohorte rekrutiert wird, halte ich diese Begründung für wenig stichhaltig. Ich gehe eher davon aus, dass die Ergebnisse bislang bescheiden waren. Dies würde zu den schwachen Mono-Daten passen, die bisher mit Checkpoint-Inhibitoren erzielt worden sind. Es ist vorstellbar, dass IMGN Zwischenergebnisse der Keytruda-Kombi-Daten zunächst einmal nicht publiziert, um die KP-Maßnahmen nicht zu stören.
Bei sämtlichen Kombi-Daten muss man umgekehrt natürlich berücksichtigen, dass es sich um eine Dosiseskalation handelt, teileise also mit vergleichsweise geringen Mirvetuxima-Dosierungen gearbeitet worden ist.
Per Saldo würde ich die in der ASCO-Meldung beschriebenen Ergebnisse als neutral (bis leicht negativ) bezeichnen.
Die Mono-Daten untermauern die bislang bekannten Studienergebnisse. In gewisser Weise stellen sie für den Investoren eine zusätzliche Absicherung dar, bieten ansonsten aber nichts Neues.
Die Kombi-Daten sind nicht leicht interpretierbar:
Die Avastin-Kombi-Daten sehen zunächst einmal sehr schwach aus, einschränkend muss man jedoch bemerken, dass die Patienten wirklich stark vorbehandelt waren. Unklar ist, in welchem Ausmaß das Patientenkollektiv Platinum-sensitiv bzw. -resistent war. Insgesamt sind die Daten wohl eher negativ zu bewerten.
Die Ergebnisse der Carboplatin-Kombi bei sensitiven Patienten entspricht etwa dem, was auch mit anderen Kombi-Therapien erreicht wird.
Über die Keytruda-Kombidaten wird nicht berichtet. Begründet wird dies mit der unreifen Datenlage. Da bereits für die Expansionskohorte rekrutiert wird, halte ich diese Begründung für wenig stichhaltig. Ich gehe eher davon aus, dass die Ergebnisse bislang bescheiden waren. Dies würde zu den schwachen Mono-Daten passen, die bisher mit Checkpoint-Inhibitoren erzielt worden sind. Es ist vorstellbar, dass IMGN Zwischenergebnisse der Keytruda-Kombi-Daten zunächst einmal nicht publiziert, um die KP-Maßnahmen nicht zu stören.
Bei sämtlichen Kombi-Daten muss man umgekehrt natürlich berücksichtigen, dass es sich um eine Dosiseskalation handelt, teileise also mit vergleichsweise geringen Mirvetuxima-Dosierungen gearbeitet worden ist.
Per Saldo würde ich die in der ASCO-Meldung beschriebenen Ergebnisse als neutral (bis leicht negativ) bezeichnen.
Antwort auf Beitrag Nr.: 54.967.259 von Joschka Schröder am 17.05.17 23:07:38http://in.reuters.com/article/us-health-cancer-immunogen-idI…
HEALTH | Thu May 18, 2017 | 2:36am IST
ImmunoGen drug moving ahead in single-agent, combination trials
Latest results from a mid-stage trial of ImmunoGen Inc's experimental antibody-drug conjugate show that it shrinks or stabilizes tumors in nearly half of advanced ovarian cancer patients with at least medium levels of a key biomarker whose disease has become resistant to standard chemotherapy.
Looking at all 113 patients so far evaluated in the trial, 30 percent responded to the drug and patients lived for a median of 4.3 months without their disease progressing.
For its pivotal trial, ImmunoGen is enrolling only patients with platinum-resistant disease and medium or high levels of a biomarker known as folate receptor alpha who have received up to three prior lines of therapy. Of the 36 trial earlier-stage trial patients meeting those criteria, 47 percent responded to the drug and median progression-free survival was 6.7 months, the company said on Wednesday. The full research will be presented next month at a meeting of the American Society of Clinical Oncology.
"We are looking to get on the market as quickly as possible in the single agent setting," ImmunoGen Chief Executive Mark Enyedy told Reuters. The company expects to have final data from the pivotal trial in 2019.
About 22,400 American women are diagnosed with ovarian cancer each year and about 14,000 will die from the disease, according to the American Cancer Society.
Mirvetuximab soravtansine combines an antibody targeting a receptor, anti-folate alpha, associated with certain types of cancer cells with an anti-tumor agent to kill the targeted cells.
ImmunoGen is also studying the drug in combination with other treatments for earlier-stage ovarian cancer, and said it will move forward with more advanced combination trials involving Roche Holding AG's Avastin and Merck & Co Inc's Keytruda. It is also evaluating future studies with carboplatin chemotherapy combinations.
Early-stage trial results showed that for advanced ovarian cancer patients treated with Avastin and the ImmunoGen antibody-drug conjugate, 29 percent responded to the treatment with a median progression-free survival of 9.5 months.
ALSO IN HEALTH
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Side effects in the Avastin group included excess protein in the urine for 36 percent of patients and hypertension in 21 percent of patients.
ImmunoGen said it was too early to assess results for the Keytruda arm of the trial.
HEALTH | Thu May 18, 2017 | 2:36am IST
ImmunoGen drug moving ahead in single-agent, combination trials
Latest results from a mid-stage trial of ImmunoGen Inc's experimental antibody-drug conjugate show that it shrinks or stabilizes tumors in nearly half of advanced ovarian cancer patients with at least medium levels of a key biomarker whose disease has become resistant to standard chemotherapy.
Looking at all 113 patients so far evaluated in the trial, 30 percent responded to the drug and patients lived for a median of 4.3 months without their disease progressing.
For its pivotal trial, ImmunoGen is enrolling only patients with platinum-resistant disease and medium or high levels of a biomarker known as folate receptor alpha who have received up to three prior lines of therapy. Of the 36 trial earlier-stage trial patients meeting those criteria, 47 percent responded to the drug and median progression-free survival was 6.7 months, the company said on Wednesday. The full research will be presented next month at a meeting of the American Society of Clinical Oncology.
"We are looking to get on the market as quickly as possible in the single agent setting," ImmunoGen Chief Executive Mark Enyedy told Reuters. The company expects to have final data from the pivotal trial in 2019.
About 22,400 American women are diagnosed with ovarian cancer each year and about 14,000 will die from the disease, according to the American Cancer Society.
Mirvetuximab soravtansine combines an antibody targeting a receptor, anti-folate alpha, associated with certain types of cancer cells with an anti-tumor agent to kill the targeted cells.
ImmunoGen is also studying the drug in combination with other treatments for earlier-stage ovarian cancer, and said it will move forward with more advanced combination trials involving Roche Holding AG's Avastin and Merck & Co Inc's Keytruda. It is also evaluating future studies with carboplatin chemotherapy combinations.
Early-stage trial results showed that for advanced ovarian cancer patients treated with Avastin and the ImmunoGen antibody-drug conjugate, 29 percent responded to the treatment with a median progression-free survival of 9.5 months.
ALSO IN HEALTH
EU to propose 10-year license renewal for weed killer glyphosate
Pfizer drug from Medivation deal shows promise in breast cancer: study
Side effects in the Avastin group included excess protein in the urine for 36 percent of patients and hypertension in 21 percent of patients.
ImmunoGen said it was too early to assess results for the Keytruda arm of the trial.
Kommentar folgt später.
ImmunoGen Announces New Clinical Data with Mirvetuximab Soravtansine in Ovarian Cancer to be Presented at 2017 ASCO Annual Meeting
Pooled analyses of Phase 1 expansion cohorts demonstrate clinically meaningful activity in patient population being studied in FORWARD I registration trial
Top-line data from FORWARD II indicate favorable safety and efficacy profile in multiple combinations
Conference call scheduled for 8:00am ET on Friday, May 19
WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced promising safety and efficacy data from monotherapy and combination studies with mirvetuximab soravtansine in patients with folate receptor alpha (FRα)-positive epithelial ovarian cancer (EOC). These data include results from pooled analyses of three Phase 1 expansion cohorts and from a Phase 1b/2 study, FORWARD II, evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab), carboplatin, Doxil® (pegylated liposomal doxorubicin), or Keytruda® (pembrolizumab). These results will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held June 2-7, 2017 in Chicago, IL.
Anti-Tumor Activity and Safety Analyses in Pooled Phase 1 Expansion Cohorts
Data from the pooled analyses demonstrate the safety and efficacy profile of mirvetuximab soravtansine in the patient population eligible for the ongoing Phase 3 registration trial, FORWARD I. These data include 113 EOC patients treated with mirvetuximab soravtansine in three expansion cohorts in the Phase 1 trial. In the subset of 36 patients meeting the key eligibility criteria for FORWARD I, which includes patients with platinum-resistant disease and medium or high levels of FRα and who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 47 percent (95% CI 30, 65) and median progression-free survival (mPFS) was 6.7 months (95% CI 4.1, 8.3).
"The data observed with mirvetuximab compare favorably with outcomes typically achieved with currently available single-agent therapies for platinum resistant ovarian cancer. Current single-agent therapies for platinum-resistant ovarian cancer have low response rates of 15 to 20% and short median progression-free survival of three to four months," stated Kathleen Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma. "Based on the consistent safety and efficacy seen with mirvetuximab soravtansine reflected in these pooled analyses, particularly in those patients meeting the eligibility criteria for the pivotal study, I am very encouraged about the potential of this compound in patients with platinum-resistant ovarian cancer and look forward to continued progress with the ongoing Phase 3 FORWARD I trial."
For all 113 patients, the median number of prior regimens was 3, 85 percent had platinum-resistant disease, 67 percent had prior bevacizumab, and 22 percent had a prior poly (ADP-ribose) polymerase (PARP) inhibitor. The safety profile of the pooled population was consistent with data previously reported (2016 ASCO Annual Meeting), which consisted primarily of low grade, manageable adverse events. In this heavily pretreated group of patients, the confirmed ORR was 30 percent (95% CI 22, 39) and mPFS was 4.3 months (95% CI 3.9, 5.4).
Initial Safety and Preliminary Efficacy Data from FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin®, carboplatin, Doxil® or Keytruda® in patients with FRα-positive EOC, primary peritoneal, or fallopian tube tumors. The data from these arms demonstrate mirvetuximab soravtansine may complement currently available therapies for FRα-positive EOC in a range of treatment settings, including earlier lines of therapy.
The safety profiles for these combinations were manageable and as expected, based on known profiles of each agent, with no new safety signals identified. Key findings in over 60 patients from the dose escalation phase of FORWARD II are as follows:
Patients in the Avastin® arm were heavily pretreated with a median of six prior regimens. The confirmed ORR for this arm was 29 percent (95% CI 8, 58), with a median PFS of 9.5 months (95% CI 3.5, 15.2).
Patients with recurrent platinum-sensitive disease on the carboplatin arm had received a median of three prior regimens and the confirmed ORR was 65 percent (95% CI 38, 86), with a median PFS of 12.1 months (95% CI 9.0, 15.0).
Patients on the Doxil® arm received a median of two prior regimens. The confirmed ORR for the Doxil® arm was 13 percent (95% CI 2, 38), with a median PFS of 7.0 months (95% CI 1.7, upper bound not estimated).
Preliminary data from the Keytruda® arm demonstrate that, similar to the other combinations, full doses of each agent are combinable. At this time, it is too early to assess anti-tumor activity data in this arm; anti-tumor activity will be reported at a subsequent medical meeting.
Based on the encouraging profiles of these combinations in dose escalation, ImmunoGen is moving forward with expansion cohorts for Avastin® and Keytruda® and is evaluating future studies with carboplatin combinations.
"The favorable safety profile of mirvetuximab soravtansine lends itself well to combination, as evidenced by the data from FORWARD II, showing the full dose of mirvetuximab soravtansine combines with the full doses of bevacizumab (Avastin®), carboplatin, pembrolizumab (Keytruda®) and pegylated liposomal doxorubicin (Doxil®) in ovarian cancer," stated David O'Malley, M.D., Associate Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center.
FORWARD I Trial
The Phase 3 FORWARD I trial was designed based on the promising monotherapy mirvetuximab soravtansine data from the Phase 1 trial and reflects the fastest registration strategy to obtain full approval of mirvetuximab soravtansine as single-agent therapy.
FORWARD I is a registration trial in which 333 patients will be randomized 2:1 and will receive either mirvetuximab soravtansine or the physicians' choice of therapy (Doxil®, paclitaxel, or topotecan). The study is currently enrolling in North America and Europe, with more than 100 sites expected to be activated in these geographies.
"The Phase 1 expansion cohort data being presented at ASCO support the potential of mirvetuximab soravtansine in the patient population eligible for FORWARD I," said Mark Enyedy, ImmunoGen's president and chief executive officer. "With the safety and efficacy profile demonstrated by these data, we look forward to completing enrollment in FORWARD I and evaluating mirvetuximab soravtansine with other therapies, including novel agents, in earlier lines of treatment."
ASCO Presentation Details:
Saturday, June 3, 2017
Title: Mirvetuximab soravtansine (IMGN853), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in platinum-resistant epithelial ovarian cancer (EOC) patients (pts): Activity and safety analyses in phase I pooled expansion cohorts.
Presenter: Kathleen N. Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma
Time: 1:15pm - 4:45pm CDT
Location: Poster Board No.: 369, Location: Hall A
Abstract: 5547
Title: Safety findings from FORWARD II: A phase 1b study evaluating the folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) mirvetuximab soravtansine (IMGN853) in combination with bevacizumab, carboplatin, pegylated liposomal doxorubicin (PLD), or pembrolizumab in patients (pts) with ovarian cancer.
Presenter: David O'Malley, M.D., Associate Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center
Time: 1:15pm - 4:45pm CDT
Location: Poster Board No.: 375, Location: Hall A
Abstract: 5553
Title: FORWARD I (GOG 3011): A randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer.
Presenter: Kathleen N. Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma
Time: 1:15pm - 4:45pm CDT
Location: Poster Board No.: 425b, Location: Hall A
Abstract: TPS5607
Additional information - including presentation schedule and full abstracts - can be found www.asco.org.
Conference Call Information
ImmunoGen will host a conference call on Friday, May 19 at 8:00am ET. At this briefing, ImmunoGen will discuss the data being presented at the 2017 ASCO Annual Meeting. To access the live call by phone, dial 719-325-2402; the conference ID is 4522749. The call may also be accessed through the "Investors" section of the Company's website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through June 1, 2017.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen's lead candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen's ADC technology is used in Roche's marketed product, Kadcyla®, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.
Avastin®, Doxil®, Keytruda® and Kadcyla® are registered trademarks of their respective owners.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.
This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including mirvetuximab soravtansine, including risks related to preclinical and clinical studies, their timings and results. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and other reports filed with the Securities and Exchange Commission.
ImmunoGen Announces New Clinical Data with Mirvetuximab Soravtansine in Ovarian Cancer to be Presented at 2017 ASCO Annual Meeting
Pooled analyses of Phase 1 expansion cohorts demonstrate clinically meaningful activity in patient population being studied in FORWARD I registration trial
Top-line data from FORWARD II indicate favorable safety and efficacy profile in multiple combinations
Conference call scheduled for 8:00am ET on Friday, May 19
WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced promising safety and efficacy data from monotherapy and combination studies with mirvetuximab soravtansine in patients with folate receptor alpha (FRα)-positive epithelial ovarian cancer (EOC). These data include results from pooled analyses of three Phase 1 expansion cohorts and from a Phase 1b/2 study, FORWARD II, evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab), carboplatin, Doxil® (pegylated liposomal doxorubicin), or Keytruda® (pembrolizumab). These results will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held June 2-7, 2017 in Chicago, IL.
Anti-Tumor Activity and Safety Analyses in Pooled Phase 1 Expansion Cohorts
Data from the pooled analyses demonstrate the safety and efficacy profile of mirvetuximab soravtansine in the patient population eligible for the ongoing Phase 3 registration trial, FORWARD I. These data include 113 EOC patients treated with mirvetuximab soravtansine in three expansion cohorts in the Phase 1 trial. In the subset of 36 patients meeting the key eligibility criteria for FORWARD I, which includes patients with platinum-resistant disease and medium or high levels of FRα and who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 47 percent (95% CI 30, 65) and median progression-free survival (mPFS) was 6.7 months (95% CI 4.1, 8.3).
"The data observed with mirvetuximab compare favorably with outcomes typically achieved with currently available single-agent therapies for platinum resistant ovarian cancer. Current single-agent therapies for platinum-resistant ovarian cancer have low response rates of 15 to 20% and short median progression-free survival of three to four months," stated Kathleen Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma. "Based on the consistent safety and efficacy seen with mirvetuximab soravtansine reflected in these pooled analyses, particularly in those patients meeting the eligibility criteria for the pivotal study, I am very encouraged about the potential of this compound in patients with platinum-resistant ovarian cancer and look forward to continued progress with the ongoing Phase 3 FORWARD I trial."
For all 113 patients, the median number of prior regimens was 3, 85 percent had platinum-resistant disease, 67 percent had prior bevacizumab, and 22 percent had a prior poly (ADP-ribose) polymerase (PARP) inhibitor. The safety profile of the pooled population was consistent with data previously reported (2016 ASCO Annual Meeting), which consisted primarily of low grade, manageable adverse events. In this heavily pretreated group of patients, the confirmed ORR was 30 percent (95% CI 22, 39) and mPFS was 4.3 months (95% CI 3.9, 5.4).
Initial Safety and Preliminary Efficacy Data from FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin®, carboplatin, Doxil® or Keytruda® in patients with FRα-positive EOC, primary peritoneal, or fallopian tube tumors. The data from these arms demonstrate mirvetuximab soravtansine may complement currently available therapies for FRα-positive EOC in a range of treatment settings, including earlier lines of therapy.
The safety profiles for these combinations were manageable and as expected, based on known profiles of each agent, with no new safety signals identified. Key findings in over 60 patients from the dose escalation phase of FORWARD II are as follows:
Patients in the Avastin® arm were heavily pretreated with a median of six prior regimens. The confirmed ORR for this arm was 29 percent (95% CI 8, 58), with a median PFS of 9.5 months (95% CI 3.5, 15.2).
Patients with recurrent platinum-sensitive disease on the carboplatin arm had received a median of three prior regimens and the confirmed ORR was 65 percent (95% CI 38, 86), with a median PFS of 12.1 months (95% CI 9.0, 15.0).
Patients on the Doxil® arm received a median of two prior regimens. The confirmed ORR for the Doxil® arm was 13 percent (95% CI 2, 38), with a median PFS of 7.0 months (95% CI 1.7, upper bound not estimated).
Preliminary data from the Keytruda® arm demonstrate that, similar to the other combinations, full doses of each agent are combinable. At this time, it is too early to assess anti-tumor activity data in this arm; anti-tumor activity will be reported at a subsequent medical meeting.
Based on the encouraging profiles of these combinations in dose escalation, ImmunoGen is moving forward with expansion cohorts for Avastin® and Keytruda® and is evaluating future studies with carboplatin combinations.
"The favorable safety profile of mirvetuximab soravtansine lends itself well to combination, as evidenced by the data from FORWARD II, showing the full dose of mirvetuximab soravtansine combines with the full doses of bevacizumab (Avastin®), carboplatin, pembrolizumab (Keytruda®) and pegylated liposomal doxorubicin (Doxil®) in ovarian cancer," stated David O'Malley, M.D., Associate Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center.
FORWARD I Trial
The Phase 3 FORWARD I trial was designed based on the promising monotherapy mirvetuximab soravtansine data from the Phase 1 trial and reflects the fastest registration strategy to obtain full approval of mirvetuximab soravtansine as single-agent therapy.
FORWARD I is a registration trial in which 333 patients will be randomized 2:1 and will receive either mirvetuximab soravtansine or the physicians' choice of therapy (Doxil®, paclitaxel, or topotecan). The study is currently enrolling in North America and Europe, with more than 100 sites expected to be activated in these geographies.
"The Phase 1 expansion cohort data being presented at ASCO support the potential of mirvetuximab soravtansine in the patient population eligible for FORWARD I," said Mark Enyedy, ImmunoGen's president and chief executive officer. "With the safety and efficacy profile demonstrated by these data, we look forward to completing enrollment in FORWARD I and evaluating mirvetuximab soravtansine with other therapies, including novel agents, in earlier lines of treatment."
ASCO Presentation Details:
Saturday, June 3, 2017
Title: Mirvetuximab soravtansine (IMGN853), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in platinum-resistant epithelial ovarian cancer (EOC) patients (pts): Activity and safety analyses in phase I pooled expansion cohorts.
Presenter: Kathleen N. Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma
Time: 1:15pm - 4:45pm CDT
Location: Poster Board No.: 369, Location: Hall A
Abstract: 5547
Title: Safety findings from FORWARD II: A phase 1b study evaluating the folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) mirvetuximab soravtansine (IMGN853) in combination with bevacizumab, carboplatin, pegylated liposomal doxorubicin (PLD), or pembrolizumab in patients (pts) with ovarian cancer.
Presenter: David O'Malley, M.D., Associate Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center
Time: 1:15pm - 4:45pm CDT
Location: Poster Board No.: 375, Location: Hall A
Abstract: 5553
Title: FORWARD I (GOG 3011): A randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer.
Presenter: Kathleen N. Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma
Time: 1:15pm - 4:45pm CDT
Location: Poster Board No.: 425b, Location: Hall A
Abstract: TPS5607
Additional information - including presentation schedule and full abstracts - can be found www.asco.org.
Conference Call Information
ImmunoGen will host a conference call on Friday, May 19 at 8:00am ET. At this briefing, ImmunoGen will discuss the data being presented at the 2017 ASCO Annual Meeting. To access the live call by phone, dial 719-325-2402; the conference ID is 4522749. The call may also be accessed through the "Investors" section of the Company's website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through June 1, 2017.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen's lead candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen's ADC technology is used in Roche's marketed product, Kadcyla®, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.
Avastin®, Doxil®, Keytruda® and Kadcyla® are registered trademarks of their respective owners.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.
This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including mirvetuximab soravtansine, including risks related to preclinical and clinical studies, their timings and results. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and other reports filed with the Securities and Exchange Commission.
Die Kursentwicklung spiegelt einmal mehr die extrem kurzfristige Sicht der meisten Börsenteilnehmer wieder. Kursanstieg innerhalb weniger Tage um 30 % ausschließlich getrieben durch die Hoffnung auf gute ASCO-Ergebnisse ... wann die ASCO-Tagung stattfindet und dass IMGN in diesem Zusammenhang schon vor Wochen/Monaten (!) gute Studienergebnisse in Aussicht gestellt hat, sollte doch eigentlich allgemein bekannt sein.
Angesichts der großen Erwartungshaltung wird IMGN nun auch liefern müssen. Man darf gespannt sein, inwieweit dies zum jetzigen Zeitpunkt in der gewünschten Form überhaupt möglich ist (bislang ist die Dosiseskalation der Kombistudie für einige Studienarme beendet, zusätzliche Daten aus einer Erweiterungskohorte kann es - in welchem Umfang? - nur für die Avastin-Kombi geben).
Interessant wird auch der Vergleich mit den Kombidaten anderer Studien (z.B. Avastin + Tecentriq) sein. Diese Daten sind bislang auch IMGN nicht bekannt.
Angesichts der großen Erwartungshaltung wird IMGN nun auch liefern müssen. Man darf gespannt sein, inwieweit dies zum jetzigen Zeitpunkt in der gewünschten Form überhaupt möglich ist (bislang ist die Dosiseskalation der Kombistudie für einige Studienarme beendet, zusätzliche Daten aus einer Erweiterungskohorte kann es - in welchem Umfang? - nur für die Avastin-Kombi geben).
Interessant wird auch der Vergleich mit den Kombidaten anderer Studien (z.B. Avastin + Tecentriq) sein. Diese Daten sind bislang auch IMGN nicht bekannt.
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Antwort auf Beitrag Nr.: 54.957.482 von kmastra am 16.05.17 20:32:51Cowen gewichtet das offensichtlich anders. Für mich sind die Forward 2-Zwischenergebnisse (Mirvet.-Kombitherapie) von größerem Interesse. Bei den P1-Monodaten sollte es eigentlich keine Überraschungen mehr geben, die wesentlichen Daten sind ja bereits bekannt.
Antwort auf Beitrag Nr.: 54.957.449 von Nase_weis_nix am 16.05.17 20:29:19
Das ist ein sehr guter Hinweis. Diese Textpassage ist mir ebenfalls ins Auge gefallen, als ich nach dem letzten CC noch einmal das Protokoll durchgelesen habe. Eigentlich ist es sehr unüblich, dass in der Zeit zwischen Abstract-Veröffentlichung und Kongresspräsentation wesentliche Neuigkeiten bekannt gegeben werden, dies behält man sich für die Präsentation vor. Es gibt allerdings seltene Ausnahmen, bewußt habe ich dies eigentlich erst einmal erlebt ... und zwar bei ImmunoGen vor genau einem Jahr (18.5.2016), als nämlich parallel zur ASCO-Abstract-Freigabe eine PR-Mitteilung veröffentlicht worden ist, in der der (zu positive) Inhalt des Abstracts durch (weitaus schlechtere) aktuelle Daten ersetzt worden ist. Vermutlich wollte sich IMGN damals präventiv gegen etwaige spätere Schadensersatzansprüche (durch das Abstract) "irregeleiteter" Aktienkäufer absichern.
Weil man im Grunde genommen nie genau weiß, was kommt, habe ich es so gehalten, dass ich ich bei Kursen um 4,90 USD Teilverkäufe durchgeführt habe, zumal der IMGN-Depotanteil infolge des zurückliegenden Kursanstiegs (Verdreifachuung innerhalb eines halben Jahres) zu groß geworden war.
Nach dem ASCO-Meeting, wenn die Poster mit allen Details vorliegen, werde ich mir Gedanken über Umfang und Kursziel meiner langfristigen (Rest-)Aktienposition machen.
Spannend wird die Sache auf jeden Fall. Insbesondere bin ich gespannt, wie groß die Avastin+Mirvetuximab-Kohorte in der Forward 2-Studie mittlerweile ist (und damit verbunden, wie aussagekräftig deren Zwischenergebnisse sind).
Zitat von Nase_weis_nix: Auszug aus https://finance.yahoo.com/news/edited-transcript-imgn-earnin…
At the ASCO annual meeting in June, we will be presenting new safety and efficacy data relating to mirvetuximab, which we will cover in greater detail when the abstracts become available later this month.
Das ist ein sehr guter Hinweis. Diese Textpassage ist mir ebenfalls ins Auge gefallen, als ich nach dem letzten CC noch einmal das Protokoll durchgelesen habe. Eigentlich ist es sehr unüblich, dass in der Zeit zwischen Abstract-Veröffentlichung und Kongresspräsentation wesentliche Neuigkeiten bekannt gegeben werden, dies behält man sich für die Präsentation vor. Es gibt allerdings seltene Ausnahmen, bewußt habe ich dies eigentlich erst einmal erlebt ... und zwar bei ImmunoGen vor genau einem Jahr (18.5.2016), als nämlich parallel zur ASCO-Abstract-Freigabe eine PR-Mitteilung veröffentlicht worden ist, in der der (zu positive) Inhalt des Abstracts durch (weitaus schlechtere) aktuelle Daten ersetzt worden ist. Vermutlich wollte sich IMGN damals präventiv gegen etwaige spätere Schadensersatzansprüche (durch das Abstract) "irregeleiteter" Aktienkäufer absichern.
Weil man im Grunde genommen nie genau weiß, was kommt, habe ich es so gehalten, dass ich ich bei Kursen um 4,90 USD Teilverkäufe durchgeführt habe, zumal der IMGN-Depotanteil infolge des zurückliegenden Kursanstiegs (Verdreifachuung innerhalb eines halben Jahres) zu groß geworden war.
Nach dem ASCO-Meeting, wenn die Poster mit allen Details vorliegen, werde ich mir Gedanken über Umfang und Kursziel meiner langfristigen (Rest-)Aktienposition machen.
Spannend wird die Sache auf jeden Fall. Insbesondere bin ich gespannt, wie groß die Avastin+Mirvetuximab-Kohorte in der Forward 2-Studie mittlerweile ist (und damit verbunden, wie aussagekräftig deren Zwischenergebnisse sind).
Antwort auf Beitrag Nr.: 54.957.449 von Nase_weis_nix am 16.05.17 20:29:19... Abstracts veröffentlicht werden (Heute 23:00 MESZ).
Korrektur: Mittwoch, den 17.05. werden die ASCO Abstracts veröffentlicht, wie JS richtig schreibt.
Korrektur: Mittwoch, den 17.05. werden die ASCO Abstracts veröffentlicht, wie JS richtig schreibt.
Antwort auf Beitrag Nr.: 54.955.175 von Joschka Schröder am 16.05.17 16:12:14Das sehe ich absolut genauso. Die Erwartungen sind sehr hoch. COWEN hat die PI Präsentation (meint wohl abstract 5547) kürzlich in eine Liste von binary events im Mai aufgeführt.
Das scheint mit doch etwas übertrieben. Ist da wirklich viel Neues zu erwarten?
IMGN hat sich zudem das Recht eingeholt, Aktien direkt am Markt zu verkaufen (für 50 Mio). Das ist natürlich erstmal besser, als eine größere KE zu einem tieferen Preis, wird die Kursentwicklung aber erstmal negativ beeinflussen. Übrigens arbeitet IMGN bei den Verkäufen mit COWEN zusammen...
SG kmastra
Das scheint mit doch etwas übertrieben. Ist da wirklich viel Neues zu erwarten?
IMGN hat sich zudem das Recht eingeholt, Aktien direkt am Markt zu verkaufen (für 50 Mio). Das ist natürlich erstmal besser, als eine größere KE zu einem tieferen Preis, wird die Kursentwicklung aber erstmal negativ beeinflussen. Übrigens arbeitet IMGN bei den Verkäufen mit COWEN zusammen...
SG kmastra
Antwort auf Beitrag Nr.: 54.955.175 von Joschka Schröder am 16.05.17 16:12:14Auszug aus https://finance.yahoo.com/news/edited-transcript-imgn-earnin…
At the ASCO annual meeting in June, we will be presenting new safety and efficacy data relating to mirvetuximab, which we will cover in greater detail when the abstracts become available later this month.
Lt. conference call gibt es evtl. schon vorher einige Details, sobald die Abstracts veröffentlicht werden (Heute 23:00 MESZ).
Des Weiteren wurde die letzten Tage klar, dass die genehmigten Kapitalerhöhungen (50 Mio USD am Markt http://investor.immunogen.com/secfiling.cfm?filingID=1047469…+ 150 Mio USD registriert = 200 Mio USD http://investor.immunogen.com/secfiling.cfm?filingID=1047469…) nicht mehr vor den Abstract-Veröffentlichungen durchgeführt werden und somit die Daten positiv sein müssten. Der Kursanstieg der letzten Tage hängt m.e. hauptsächlich mit dieser Spekulation zusammen.
Was danach passiert ist ungewiss. Aber IMGN rechnet wohl mit steigenden Kursen, wodurch man auf entsprechend gute Daten rückschließen könnte.
Mark Enyedy hat beim cc die genehmigten Kapitalerhöhungen elegant weggelassen, bzw. umschifft und ausschließlich alternative Finanzierungsformen angesprochen:
So we share your view on the balance sheet and our focus intensely -- everything is dilutive at one level I suppose. But fundamentally, as we mentioned on our last call, we look to prioritize the portfolio and so we chose to target our B-cell programs for out-licensing and so there's active interest there, which we are pursuing as we speak. In addition to that, as you know, we have a number of agreements that provide for downstream royalty obligations. And so we continue to explore the possibility of monetizing those royalty streams for upfront cash. And then finally, we are entertaining interest in our development stage programs with respect to codevelopment and cocommercialization, arrangements for those programs that would enable us to generate upfront cash as well as mitigate our ongoing expenses, while retaining substantive commercial rights in those programs downstream. And so we are actively exploring each one of those avenues as we speak with the goal of, as you say, improving the shape of the balance sheet.
Nach meinem Kenntnisstand gibt es keine ASCO-Abstracts bzgl. Anetumab Ravtansine. Das ist das einzige fortgeschrittene Projekt, welches eine Monetarisierung der Royalities erlauben würde. Aufgrund niedriger langfristiger Zinssätze könnten sich solche Monetarisierungs-Verträge aktuell rentieren. Aber lukrativ verkaufen lässt sich das wohl nur, wenn sichtbar wird, welche Umsätze Bayer damit wirklich erzielen kann.
Ich warte daher weiter ab und halte IMGN mit nur kleineren Verkäufen zur Zeit. Die Kaptialerhöhung(en) kommen m.e. nach ASCO oder bei starkem Kursanstieg bereits vorher.
At the ASCO annual meeting in June, we will be presenting new safety and efficacy data relating to mirvetuximab, which we will cover in greater detail when the abstracts become available later this month.
Lt. conference call gibt es evtl. schon vorher einige Details, sobald die Abstracts veröffentlicht werden (Heute 23:00 MESZ).
Des Weiteren wurde die letzten Tage klar, dass die genehmigten Kapitalerhöhungen (50 Mio USD am Markt http://investor.immunogen.com/secfiling.cfm?filingID=1047469…+ 150 Mio USD registriert = 200 Mio USD http://investor.immunogen.com/secfiling.cfm?filingID=1047469…) nicht mehr vor den Abstract-Veröffentlichungen durchgeführt werden und somit die Daten positiv sein müssten. Der Kursanstieg der letzten Tage hängt m.e. hauptsächlich mit dieser Spekulation zusammen.
Was danach passiert ist ungewiss. Aber IMGN rechnet wohl mit steigenden Kursen, wodurch man auf entsprechend gute Daten rückschließen könnte.
Mark Enyedy hat beim cc die genehmigten Kapitalerhöhungen elegant weggelassen, bzw. umschifft und ausschließlich alternative Finanzierungsformen angesprochen:
So we share your view on the balance sheet and our focus intensely -- everything is dilutive at one level I suppose. But fundamentally, as we mentioned on our last call, we look to prioritize the portfolio and so we chose to target our B-cell programs for out-licensing and so there's active interest there, which we are pursuing as we speak. In addition to that, as you know, we have a number of agreements that provide for downstream royalty obligations. And so we continue to explore the possibility of monetizing those royalty streams for upfront cash. And then finally, we are entertaining interest in our development stage programs with respect to codevelopment and cocommercialization, arrangements for those programs that would enable us to generate upfront cash as well as mitigate our ongoing expenses, while retaining substantive commercial rights in those programs downstream. And so we are actively exploring each one of those avenues as we speak with the goal of, as you say, improving the shape of the balance sheet.
Nach meinem Kenntnisstand gibt es keine ASCO-Abstracts bzgl. Anetumab Ravtansine. Das ist das einzige fortgeschrittene Projekt, welches eine Monetarisierung der Royalities erlauben würde. Aufgrund niedriger langfristiger Zinssätze könnten sich solche Monetarisierungs-Verträge aktuell rentieren. Aber lukrativ verkaufen lässt sich das wohl nur, wenn sichtbar wird, welche Umsätze Bayer damit wirklich erzielen kann.
Ich warte daher weiter ab und halte IMGN mit nur kleineren Verkäufen zur Zeit. Die Kaptialerhöhung(en) kommen m.e. nach ASCO oder bei starkem Kursanstieg bereits vorher.
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