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ASCO 2016 Exelixis-Discovered Compounds to Be Featured in 18 Presentations at 2016 ASCO Annual Meeting SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr. 20, 2016-- Exelixis, Inc. (NASDAQ: EXEL) today announced that new data for cabozantinib, cobimetinib and XL888 will be presented at the upcoming 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3 – 7, 2016. An oral presentation will include pivotal overall survival data from the METEOR study, the randomized phase 3 trial of cabozantinib versus everolimus in patients with previously treated advanced renal cell carcinoma (RCC). These data were submitted to the U.S. Food and Drug Administration (FDA) in the New Drug Application (NDA) for cabozantinib for patients with advanced RCC who have received one prior therapy. On January 28, 2016 Exelixis announced that the FDA accepted the NDA for cabozantinib. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016. Additional presentations at ASCO will highlight results from early and mid-stage trials of cabozantinib in other disease settings, including metastatic colorectal cancer, endometrial cancer and metastatic urothelial carcinomas. “The overall survival data for cabozantinib from the METEOR trial represent an important milestone in the treatment of advanced renal cell carcinoma,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “When taken alongside data from the trial’s other endpoints, this result makes cabozantinib the first therapy to demonstrate improvements in the three key measures of efficacy in a large randomized phase 3 trial of patients with this advanced form of cancer. Exelixis is committed to ongoing clinical research for patients who need new treatment options, and the slate of data for Exelixis-discovered compounds at this year’s ASCO Annual Meeting speaks to the urgency with which we and our collaborators are working to improve care and outcomes for patients with cancer.” Cabozantinib will be the subject of nine presentations. The full schedule of cabozantinib presentations expected at the meeting is as follows (all times are in Central Daylight Time): Oral Presentations: [4506] “Overall survival (OS) in METEOR, a randomized phase 3 trial of cabozantinib (Cabo) versus everolimus (Eve) in patients (pts) with advanced renal cell carcinoma (RCC).” Dr. Toni K. Choueiri, Dana Farber Cancer Institute, Boston, Massachusetts Oral Abstract Session: Genitourinary (Nonprostate) Cancer: 8 – 11 a.m. Sunday, June 5, 10:12 – 10:24 a.m. Poster Presentations [9068] “MDM2 amplification (Amp) to mediate cabozantinib resistance in patients (Pts) with advanced RET-rearranged lung cancers.” Romel Somwar, Memorial Sloan Kettering Cancer Center, New York, New York Poster Session: Lung Cancer—Non-Small Cell Metastatic Poster presented Saturday, June 4, 8 – 11:30 a.m., Hall A (Poster #391) Note: This is an Investigator-Sponsored Trial. [3548] “Phase Ib study of cabozantinib plus panitumumab in KRAS wild-type (WT) metastatic colorectal cancer (mCRC).” Dr. John Strickler, Duke University Medical Center, Durham, North Carolina Poster Session: Gastrointestinal (Colorectal) Cancer Poster presented Saturday, June 4, 8 – 11:30 a.m., Hall A (Poster #245) Note: This is an Investigator-Sponsored Trial. [2565] “Population pharmacokinetic (PopPK) and exposure-response (ER) modeling of cabozantinib (C) in patients (pts) with renal cell carcinoma (RCC) in the phase 3 METEOR study.” Dr. Steve Lacy, Exelixis, Inc., South San Francisco, California Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics Poster presented Sunday, June 5, 8 – 11:30 a.m., Hall A (Poster #265) [1093] “Effect of cabozantinib treatment on circulating immune cell populations in patients with metastatic triple-negative breast cancer (TNBC).” Dr. Dan G. Duda, Massachusetts General Hospital, Boston. Massachusetts Poster Session: Breast Cancer—Triple-Negative/Cytotoxics/Local Therapy Poster presented Sunday, June 5, 8 – 11:30 a.m., Hall A (Poster #198) Note: This is an Investigator-Sponsored Trial. [4534] “A phase II study of cabozantinib in patients (pts) with relapsed or refractory metastatic urothelial carcinoma (mUC).” Dr. Andrea Borghese Apolo, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Washington, D.C. Poster Discussion Session: Genitourinary (Nonprostate) Cancer Poster presented Monday, June 6, 1 – 4:30 p.m., Hall A; discussed at 4:45 – 6 p.m. in Arie Crown Theater Note: This is a National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) study. [4558] “Efficacy of cabozantinib (C) vs everolimus (E) in patients (pts) with advanced renal cell carcinoma (RCC) and bone metastases (mets) from the phase III METEOR study.” Dr. Bernard Escudier, Institut Gustave Roussy, Villejuif, France Poster Session: Genitourinary (Nonprostate) Cancer Poster presented, Monday, June 6, 1 – 4:30 p.m., Hall A (Poster #180) [4557] “Outcomes based on prior VEGFR TKI and PD-1 checkpoint inhibitor therapy in METEOR, a randomized phase 3 trial of cabozantinib (C) vs everolimus (E) in advanced renal cell carcinoma (RCC).” Dr. Thomas Powles, Barts Cancer Institute, Queen Mary University, London, England Poster Session: Genitourinary (Nonprostate) Cancer Poster Presented Monday, June 6, 1 – 4:30 p.m., Hall A (Poster #179) [5586] “Phase II study of cabozantinib in recurrent/metastatic endometrial cancer (EC): a study of the Princess Margaret, Chicago and California Phase II Consortia.” Dr. Neesha Dhani, Princess Margaret Cancer Centre, University Health Network, Chicago, Illinois Poster Session: Gynecologic Cancer Poster Presented Monday, June 6, 1 – 4:30 p.m., Hall A (Poster #409) Note: This is an NCI-CTEP study. Investor/Analyst Briefing to Review Cabozantinib Data Exelixis will host a live investor/analyst briefing on Sunday, June 5, 2016, from 7:30-9:30 p.m. EDT / 6:30-8:30 p.m. CDT / 4:30-6:30 p.m. PDT. During the briefing, Exelixis management and invited guest speakers will review and provide context for cabozantinib data presented at the ASCO Annual Meeting. The briefing will be webcasted. To access the webcast, log onto www.exelixis.com and proceed to the Event Calendar page under Investors & Media. Please connect to the company’s website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be required to listen to the webcast. An archived replay of the webcast will be available on the Event Calendar page under Investors & Media at www.exelixis.com for one year. A telephone replay of the webcast will be available until 11:59 p.m. EDT on June 7, 2016; please visit the Event Calendar page for details on phone replay access when available. XL888 Data to be Presented in a Poster In addition, investigational compound XL888 will be the subject of the following poster presentation (in Central Daylight Time): [9544] “Phase I study of vemurafenib and heat shock protein 90 (HSP90) inhibitor XL888 in metastatic BRAF V600 mutant melanoma.” Dr. Zeynep Eroglu, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida Poster Session: Melanoma/Skin Cancers Poster presented Saturday, June 4, 1 – 4:30 p.m., Hall A (Poster #149) Note: This is an Investigator-Sponsored Trial. Cobimetinib to be Featured in Eight Presentations Also at the meeting, Exelixis’ collaborator Genentech, a member of the Roche Group, will present data on cobimetinib, an Exelixis-discovered compound, in disease settings including colorectal cancer, triple-negative breast cancer, and BRAF-mutant melanoma. The full schedule of cobimetinib presentations expected at the meeting is as follows (all times are in Central Daylight Time): Oral Presentation: [3502] “Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC).” Dr. Johanna Bendell, Sarah Cannon Research Institute, Nashville, Tennessee Oral Abstract Session: Gastrointestinal (Colorectal) Cancer Oral presentation on Sunday, June 5, 8 – 11 a.m., Hall B1 (abstract scheduled for 8:24 – 8:36 a.m.) Poster Discussion: [9510] Extended follow-up results of a phase 1B study (BRIM7) of cobimetinib and vemurafenib in BRAF-mutant melanoma Dr. Adil Daud, University of California, San Francisco, San Francisco, California Poster Session: Melanoma/Skin Cancers Poster presentation from Saturday, June 4, 1 – 4:30 p.m. (Poster #115) in Hall A; discussion on Saturday, June 4, 4:45 – 6 p.m. in room E354b Poster Presentations: [9528] “Clinical predictors of response for coBRIM, a phase 3 study of cobimetinib (C) in combination with vemurafenib (V) in advanced BRAF-mutated melanoma (MM).” Dr. James Larkin, The Royal Marsden Hospital, London, UK Poster Session: Melanoma/Skin Cancers Saturday, June 4, 1 – 4:30 p.m., Hall A (Poster #133) [9530] “Efficacy of cobimetinib (C) and vemurafenib (V) in advanced BRAF-mutated melanoma patients (pts) with poor and favorable prognosis in the coBRIM phase 3 study.” Dr. Grant A McArthur, Peter MacCallum Cancer Centre, East Melbourne, Australia and University of Melbourne, Parkville, Australia Poster Session: Melanoma/Skin Cancers Saturday, June 4, 1 – 4:30 p.m., Hall A (Poster #135) [9533] “Adverse event (AE) incidence rates with cobimetinib (C) plus vemurafenib (V) treatment: extended follow-up (f/u) of the phase 3 coBRIM study.” Dr. Brigitte Dréno, Nantes University, Nantes, France Poster Session: Melanoma/Skin Cancers Saturday, June 4, 1 – 4:30 p.m., Hall A (Poster #138) [9536] “Identifying prognostic subgroups for outcomes in BRAFV600-mutated metastatic melanoma patients (pts) treated with vemurafenib (V) ± cobimetinib (C): A pooled analysis of BRIM-2, BRIM-3, BRIM-7 and coBRIM.” Dr. James Larkin, The Royal Marsden Hospital, London, UK Poster Session: Melanoma/Skin Cancers Saturday, June 4, 1 – 4:30 p.m., Hall A (Poster #141) [1074] “Cobimetinib (C) + paclitaxel (P) as first-line treatment in patients (pts) with advanced triple-negative breast cancer (TNBC): updated results and biomarker data from the phase 2 COLET study.” Dr. Adam Brufsky, NRG Oncology/NSABP and Magee Women's Hospital, Pittsburgh, PA Poster Session: Breast Cancer—Triple-Negative/Cytotoxics/Local Therapy Sunday, June 5, 8 – 11:30 a.m., Hall A (Poster #179) [TPS1100] “COLET (NCT02322814): A multistage, phase 2 study evaluating the safety and efficacy of cobimetinib (C) in combination with paclitaxel (P) as first- line treatment for patients (pts) with metastatic triple-negative breast cancer (TNBC).” Dr. David Miles, Mount Vernon Cancer Centre, London, UK Poster Session: Breast Cancer —Triple-Negative/Cytotoxics/Local Therapy Sunday, June 5, 8 – 11:30 a.m., Hall A (Poster #203a) |
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| aus der Diskussion: | Exelixis - auf dem Weg in die Gewinnzone? |
| Autor (Datum des Eintrages): | Ville7 (28.04.16 17:52:02) |
| Beitrag: | 2 von 299 (ID:52300606) |
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