RE: Iovances Amtagvi FDA approval first cell therapy solid tumour19 Feb 2024 12:43
Hi folks . This is my first post and I apologise in advance for my poor English. Deepl translator is my companion😁 . For your information. I have been invested in Scancell for about 4 years.
Now to the topic. I'll post the reason for authorisation from Iovance …
„ This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.“
And here are the OR‘s for this treatment.
„ The FDA approval is based on safety and efficacy results from the C-144-01 clinical trial. C-144-01 is a global, multicenter trial investigating AMTAGVI in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable. AMTAGVI demonstrated deep and durable responses. The primary efficacy analysis set included 73 patients from Cohort 4 who received the recommended AMTAGVI dose from an approved manufacturing facility. Among the 73 patients, 31.5% achieved an objective response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) with a median duration of response not reached at 18.6 months follow-up2 (43.5% of responses had a duration greater than 12 months). Additionally, the supporting pooled efficacy set included a total of 153 patients from Cohort 4 and Cohort 2. Among the 153 patients, 31.4% achieved an objective response by RECIST 1.1 with a median duration of response not reached at 21.5 months follow-up2 (54.2% of responses had a duration greater than 12 months).“
Now my point. I think Overall Response Rate and Objective Response is the same?!?!
With an ORR about 80-90% from Scib1 we could laugh about this results. Am i wrong?? Your thoughts???
Sign In
Follow the stocks
