Big Pharma Sharma's Bullets: TIVDAK’s Positive InnovaTV-301 Study, Impact to SmallCos, and Implications for Development Strategy

Speed of development and randomized studies are becoming ever more crucial in oncology drug development.

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▶️ Introduction

On Monday, September 4th, Genmab and Seagen announced positive topline P3 data from their InnovaTV-301 study of TIVDAK (tisotumab vedotin) vs. chemotherapy in 2L+ patients with R/M cervical cancer. This will serve as a confirmatory study for TIVDAK, which already won accelerated approval in 2L+ cervical cancer in 2021. 

My interest in this news is less about TIVDAK almost certainly being on track to win full approval in this high unmet need condition, it's more about what this means for other competitors looking to develop drugs in this market and development strategy at-large. Recall, in January 2022, Sanofi and Regeneron withdrew the filing of Libtayo in 2L cervical cancer, which was based on randomized P3 data. Their filing ended up being moot as Merck won approval for Keytruda + chemo in 1L PD-L1+ cervical cancer patients in October 2021, which also converted its previous approval of Keytruda monotherapy in 2L cervical cancer into a full approval. The FDA came back to Sanofi/Regeneron, supposedly requesting data in PD-L1-negative patients as a post-marketing requirement, which subsequently led the companies to pull their filing, despite positive data. For Sanofi/Regeneron, the decision likely came down to a straight cost-benefit analysis. With their drug unlikely to generate responses in PD-L1 negative patients and this being a potential requirement of sustaining a 2L+ label, the investment needed to advance Libtayo in cervical cancer was simply not going to generate sufficient returns. Moreover, a path in 1L PD-L1+ cervical cancer would now seem to go through some sort of non-inferiority study vs. Keytruda, which may not be worth it, given the market size in this indication.