Cel-Sci Corp ( CVM ) - 1 Jahr vor dem "Start", der neue Thread (Seite 8)

[Valueandi]

bin sehr gespannt den ganzen artikel zu lesen

denke die ganzen ärzte werden ihren senf dazu geben...

die frage ist ob auf ct auch zeitgleich veröffentlicht wird???

[aldy78]

Antwort auf Beitrag Nr.: 71.669.457 von Valueandi am 27.05.22 19:23:39

https://twitter.com/geertkersten1/status/1530199495237148676…

[Valueandi]

Antwort auf Beitrag Nr.: 71.669.457 von Valueandi am 27.05.22 19:23:39

Frencheese Investor
@dinhvesting
· 3 Std.
$CVM Wonderful data. This piece of news is just amazing!

[Valueandi]

Antwort auf Beitrag Nr.: 71.664.339 von Valueandi am 27.05.22 08:28:23

und tatsächlich, geerty hat den Beschwörungsgesang erhört und meldet sich auf twitter zu Wort :


Geert Kersten
@GeertKersten1
·
2 Std.
$CVM I am so proud of our team. An almost 4 year survival benefit in head and neck cancer with no toxicity added. That is why we believe!

[Valueandi]

Antwort auf Beitrag Nr.: 71.624.487 von Valueandi am 20.05.22 20:39:04

Zitat von Valueandi: bin gespannt ob geerty the huckster am 26ten aus seinem Loch kommt..

zeit ist es mal, geert

zeit geerty aus deinem Loch zu kommen...

[Valueandi]

Antwort auf Beitrag Nr.: 71.664.294 von Valueandi am 27.05.22 08:21:28

auch sehr interessant das es jede menge co autoren gibt (hauptsächlich die behandelnden Ärzte)

da wird es meiner Meinung nach sehr positive Aussagen zur kompletten Tumorremission geben

teilweise ja 16 % wo der tumor komplett verschwand noch bevor der operation, das ist ziemlich beeindruckend

welcher Patient würde so eine Behandlung verweigern ??

[Valueandi]

Antwort auf Beitrag Nr.: 71.646.264 von Valueandi am 24.05.22 19:05:43

https://meetings.asco.org/abstracts-presentations/207201



von asco seite:
Authors
person
Eyal Talor

Cel-Sci Corporation, Vienna, VA

emailMail Presenter
Eyal Talor, Dusan Markovic, Philip T Lavin, John Cipriano, Jozsef Timar, Andrey Karpenko, Igor Bondarenko, Srboljub Stosic, Hrvoje Sobat, Jayamini Horadugoda, Aliaksandr Zhukavets, Rajnish Vasant Nagarkar, Nazim Imamovic, Chih-Yen Chien, Magdalena Bankowska-Wozniak, Mihaly Kisely, Raphael Feinmesser, James Edward Young, Christopher L Oliver, Sheng-Po Hao

Organizations
Cel-Sci Corporation, Vienna, VA, Ergomed Clinical Research Ltd., Belgrade, Serbia, Lavin Consulting, Framingham, MA, 2nd Department of Pathology, Semmelweis University, Budapest, Hungary, Leningrad Regional Oncology Dispensary, Saint Petersburg, Russian Federation, City Clinical Hospital No4, Dnipro, Ukraine, Military Medical Academy, Belgrade, Serbia, KBC SESTRE MILOSRDNICE, Zagreb, Croatia, Karapitiya Teaching Hospital, Galle, Sri Lanka, N.N.Alexandrov National Cancer Centre of Belarus, Minsk, Belarus, Department of Surgical Oncology, HCG Manavata Cancer Centre, Nashik, Nashik, India, University Clinical Center Tuzla, Tuzla, Bosnia and Herzegovina, Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung City, Taiwan, Centrum Onkologii im Prof.F.Lukaszcsyka, Bydgoszcz, Poland, Markusovszky Lajos Teaching Hospital, Szombathey, Hungary, Tel Aviv University, Rabin Medical Center, Petah Tikva, Israel, McMaster University, St Joseph Health Care Hamilton, Hamilton, ON, Canada, Colorado Head and Neck Specialists, Denver, CO, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan

[Valueandi]

Antwort auf Beitrag Nr.: 71.664.276 von Valueandi am 27.05.22 08:17:47

https://meetings.asco.org/abstracts-presentations/207202

Background:
Locally advanced primary SCCHN, DDT options (radiotherapy (RTx) or concurrent Chemoradiotherapy (CRTx)) is performed only following surgery (National Comprehensive Cancer Network [NCCN] Guidelines). A novel 2-step exclusion algorithm was developed, based only on N classification and imaging (CT; MRI +/- PET) to detect clinical features only from screening/entry findings. The algorithm was developed using the IT-MATTERS SCCHN pivotal study (Clinical trials.gov NCT01265849) data to identify treatment naïve lower risk (LR) for recurrence subjects receiving neoadjuvant immunotherapy prior to surgery to optimize long-term overall survival (OS).
Methods:
SCCHN patients are routinely examined and imaged at entry/screening to establish TNM classification and disease stage. Imaging is performed using CT, MRI, and/or PET-CT/PET-MRI per NCCN Guidelines. These imaging techniques can reliably detect extracapsular cervical lymph node spread before surgery, allowing the algorithm to be constructed and validated. Algorithm rules target CRTx bound (“High-Risk”) patients leaving RTx bound (“Low-Risk”) locally advanced primary disease patients at entry. The 2-step exclusions are: (1) exclude all N2 leaving only those with N0-N1, (2) further exclude those exhibiting extra capsular spread (PET-CT or PET-MRI). We retained those determined by study physicians to receive CRTx for the algorithm validation exercise only. The n = 923 pivotal study intent to treat (ITT) population was used to validate the algorithm.
Results:
Overall algorithm coverage was 99.9% (922/923 ITT except one missing N case) with 24.6% having N2 and 75.3% N0/N1. Among algorithm exclusions, 81.3% (282/347) were High-Risk; among algorithm inclusions, 60.6% (349/576) were Low-Risk. Algorithm validation: Among all Low-Risk cases in the study (n = 380), 91.8% (349/380) met the algorithm criteria; among all High-Risk cases, 60.4% (282/467) were correctly excluded by the algorithm. Remaining were physician choice. Overall, algorithm alone predicted 74.5% (631/847) risk group (combined low and high) accurately. Significant OS advantage (2-sided log rank p = 0.0376) to Immunotherapy regimen + standard of care (SOC) surgery + RTx vs SOC alone was seen for Low-Risk cases selected only by the 2-step algorithm.
Conclusions:
The algorithm provided near perfect (99.9%) ITT population coverage, achieved near 75% overall accuracy, with 91.8% accurate predictive value for the low-risk group demonstrating significant OS. Thus, risk group can be inferred at screening consistent with clinical practice and NCCN Guidelines. The algorithm can be used to help identify low risk SCCHN patients at entry to receive neoadjuvant immunotherapy before surgery.

[Valueandi]

Antwort auf Beitrag Nr.: 71.664.267 von Valueandi am 27.05.22 08:15:17

https://meetings.asco.org/abstracts-presentations/207201

Results:
Pre-surgery responders (PSR; CR/PR) in ITT LI treated (+/- CIZ) groups were 8.5% (45/529; overall LI) and 16% (34/212; LR LI) vs no SOC PSRs. Early response lowered death rate to 22.2% (ITT LI treated) vs 54.1% for non-PSRs (two-sided Fisher Exact (2FE) p < 0.0001), for ITT LR LI PSRs with 17.6% vs 42.7% (2FE p = 0.0067), and for ITT LR LI responders (LI+CIZ+SOC) 12.5% vs 41% (2FE p = 0.0101). Proportional hazard (PH) ITT LR LI treated HR = 0.348 (95% CI: [0.152, 0.801]), ITT LR LI+CIZ+SOC HR = 0.246 (95% CI: [0.077, 0.787]). For all ITT LR (n = 380), LI+CIZ+SOC demonstrated significant OS advantage vs SOC (log rank p = 0.0478; Cox HR = 0.68 (95% CI: [0.48-0.95]), Wald p = 0.0236 [controlling for tumor stage, tumor location and geographic region]. The absolute OS advantage in ITT LR LI+CIZ+SOC vs SOC was 4.9%/9.5%/14.1%, at 36/48/60 months (M), representing 72.4% vs 67.5% (36 M); 67.3% vs 57.8% (48 M), and 62.7% vs 48.6% (60 M) with a 46.5 M median OS advantage (101.7 M [LI+CIZ+SOC] vs 55.2 M [SOC]). Percent treatment emergent adverse events (TEAEs) were comparable among all treated groups. No excess safety was reported for LI treatment over SOC alone.
Conclusions:
LI immunotherapy did not add excess safety issues or TEAEs. Early LI response decreases mortality and is OS prognostic. ITT LR LI+CIZ+SOC absolute OS advantage over SOC alone increased over time; the 0.68 HR corresponds to a 47% prolongation of median survival in a population without any new therapy options in decades. Clinical trial information: NCT01265849.

[Valueandi]

Antwort auf Beitrag Nr.: 71.664.255 von Valueandi am 27.05.22 08:13:01

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