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BeyondSpring Announces First Patient Treated in Phase 2 Study with Plinabulin Combined with Nivolumab + Ipilimumab in Patients in 3rd Line Recurrent Small-Cell Lung Cancer Patients Who Failed Checkpoint Inhibitors
—The study is conducted by the Big Ten Cancer Research Consortium in up to 26 patients across 7 states in the U.S. —In the Phase 1 study, plinabulin
About this update from Beyondspring, Inc.
[{"type":"text","content":"—The study is conducted by the Big Ten Cancer Research Consortium in up to 26 patients across 7 states in the U.S. —In the Phase 1 study, plinabulin combination was able to induce tumor responses in patients who had progressed on platinum and checkpoint inhibitors, with 43% ORR (3 partial responses with tumor reduction >50%). Duration of treatment was as long as 18 months in 1 patient. NEW YORK, Oct. 21, 2021 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, announced the first patient has been treated in an investigator-initiated, open-label Phase 2 study with lead asset plinabulin in combination with nivolumab + ipilimumab in patients with 3rd line recurrent small-cell lung cancer (SCLC) who failed checkpoint inhibitors and platinum-based chemotherapy. Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. This Phase 2 study, to be conducted through the Big Ten Cancer Research Consortium in 7 U.S. clinical centers, comes after the successful completion of the Phase 1 dose escalation study portion of this Phase 1/2 study. “For patients with extensive stage SCLC who failed chemo and checkpoint inhibitors, effective treatment options are limited. By exploring this novel immunotherapy combination and expanding on the encouraging Phase 1 data, there is an opportunity to address this unmet medical need,” commented Jyoti Malhotra, M.D., M.P.H., Principal Investigator, medical oncologist at Rutgers Cancer Institute of New Jersey. “In the Phase 1 study, the addition of plinabulin to nivolumab + ipilimumab was able to induce tumor responses in patients who failed chemotherapy and checkpoint inhibitors with ORR at 43%, double the ORR of nivolumab + ipilimumab in Checkmate 032. An added bonus is the marked reduction in Grade 3/4 IR-AEs from historical 37% to 12.5%; IR-SAE typically leads to permanent discontinuation of PD-1 and CTLA-4 combination. The ability to both enhance the anti-cancer effects and reduce the Grade 3/4 IR-AEs of PD-1 and CTLA-4 inhibitors makes plinabulin an ideal addition to these checkpoint inhibitors for establishing the concept of a ‘chemo-free’ therapeutic strategy for cancer patients.” In this Phase 2 study, up to 26 pa...