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Re: Excerpt from BofA's Read-through from J&J 4Q2021 Earnings"Eagerly awaiting subcutaneous nivolumab"? Besides prior HALO comments about late stage trial timing, BMY most recently updated details on CheckMate-67T comparing subcutaneous Nivo/Opdivo versus IV on 19Jan2022. The primary completion date is currently listed as 13Dec2023. Reasonable estimate of 6 months from locking the database to filing and 6 month review cycle for a supplemental BLA could realistically garner approval by YE2024 with 2025 marking the launch of subcutaneous Nivo. A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (CheckMate-67T)
Sponsor: Bristol-Myers Squibb Information provided by (Responsible Party): Bristol-Myers Squibb Study Description Go to Brief Summary: The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.
Study Design Go to
The following message was updated on 10/1/2021 10:38:33 AM.
Why are you "still waiting for nivolumab subcutaneous news"? - Phase III in RCC recently initiated as of 2Q2021 CC and likely tail end of 2023-2025 of HALO's list of partner late stage trialsSubcutaneous Opdivo - BMY ENHANZE programs updated to reflect HALO's 2Q2021 earnings call updateRelevant BMY-related HALO 2Q2021 excerpts include: Let's begin with the next wave of potential launches. These are called the Wave 3 launch products. These are products that are today in Phase 3 development and they include Bristol's nivolumab, Roche's Tecentriq and Argenx’s efgartigimod. Now based on historical development timelines, products today are in Phase 3 redevelopment represent potential launches in the 2023 to 2025 time frame. We had expected a fourth product to initiate a Phase 3 study this year. Recently, the partner for that program informed us that they now expect to initiate the Phase 3 study in 2022. Let me now provide that brief discussion of select partners beginning with Bristol-Myers Squibb, after indicating the start was imminent on our first quarter results call. We're pleased to confirm Bristol builds the first patient in the Phase 3 study of nivolumab using enhanced technology for patients with advanced or metastatic clear cell renal cell carcinoma during the second quarter. In addition to nivolumab, Bristol has initiated three Phase 1 studies with ENHANZE. These include studies of anti-CD73, TIM3 and the fixed dose combination of nivolumab and relatlimab. Following that, it is the products that are in Phase 1 testing. And by the end of this year, we estimate we'll have 13 products that will be in or having completed Phase 1. Now that is a terrific portfolio. And again if you look at those products as very exciting products in there and that's 2025 to 2027 would be the next potential, if those ones follow that approximately five years from first in human to approval. |
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Msg # | Subject | Author | Recs | Date Posted |
8887 | Re: Excerpt from BofA's Read-through from J&J 4Q2021 Earnings | Biotech2050 | 0 | 1/25/2022 10:43:24 AM |