CLINICAL AND REGULATORY
Nektar and BMS announced update on clinical development program for bempeg with Opdivo
Nektar and BMS announced that based on results from pre-planned analyses of two late-stage clinical studies of bempeg in combination with Opdivo in RCC and bladder cancer, the companies have jointly decided to end the global clinical development program for bempeg in combination with Opdivo. These studies and all other ongoing studies in the program will be discontinued. In the Phase 3 PIVOT-09 study in patients with previously untreated advanced or metastatic RCC, Nektar and BMS were informed by an independent DMC that a final analysis of ORR showed that bempeg in combination with Opdivo did not meet the prespecified boundary for statistical significance in comparison to the TKI control arm. An interim analysis of OS also did not meet the prespecified boundary for statistical significance in either of these populations.
Given there was no clinical benefit in the doublet therapy arm compared to the TKI arm, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint. In the separate Phase 2 PIVOT-10 study of the bempeg/Opdivo doublet in patients with cisplatin-ineligible, locally advanced or metastatic urothelial cancer, a final ORR analysis showed that bempeg in combination with Opdivo did not reach an efficacy threshold to support continuing the program in urothelial carcinoma. The companies will review the data for both studies and plan to share the results with the scientific community.
All other studies of bempeg in combination with Opdivo, including a pivotal study in muscle-invasive bladder cancer (CA045-009), a Phase 1/2 study of the doublet in combination with TKI therapy in 1L RCC (CA045-011) and a Phase 1/2 study in recurrent and/or refractory pediatric tumors (CA045-020), will be discontinued, allowing patients and their physicians to consider standard of care treatment options for their specific conditions.
Nektar presented preclinical data on NKTR-255 in combination with CAR cell therapies
Nektar announced that collaborators from the Cairo Laboratory at New York Medical College presented data from several preclinical studies demonstrating the potential of NKTR-255 to enhance the anti-tumor activities of different CAR-T therapies in a variety of cancer preclinical models. The research builds on the body of knowledge for the role of an agent which activates the full IL-15 biology pathway in the field of cell therapy. The lab's findings show that NKTR-255's ability to expand and proliferate NK cells resulted in the enhancement of the efficacy of two different CAR therapies in preclinical models.