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Fly News Breaks for March 2, 2020
Mar 2, 2020 | 12:26 EDT
William Blair analyst Andy Hsieh noted that Merck (MRK) announced that the Phase 3 KEYNOTE-204 trial testing Keytruda against Adcetris in relapsed or refractory Hodgkin lymphoma met its primary endpoint of progression-free survival and will continue as the other primary efficacy endpoint of overall survival matures. He thinks the study results revive the fear of "obsolescence, or at least significant competitive pressure," for Seattle Genetics' (SGEN) Adcetris franchise. However, while he looks forward to the full data presentation, Hsieh does not believe the KEYNOTE-204 results will lead to significant changes in the treatment paradigm for Hodgkin lymphoma and he has an Outperform rating on Seattle Genetics shares.
News For SGEN;MRK From the Last 2 Days
May 18, 2022 | 07:10 EDT
IO Biotech (IOBT) announced that it has dosed the first patient in its Phase 3 IOB-013 / KN-D18 trial. The IOB-013 / KN-D18 trial seeks to evaluate IO Biotech's lead candidate, IO102-IO103, in combination with KEYTRUDA, Merck's (MRK) anti-PD-1 therapy, in patients with previously untreated, unresectable or metastatic melanoma. "We are pleased to treat the first melanoma patient, kicking off in Florida and expanding this Phase 3 study with a therapy that has received an FDA Breakthrough Designation across multiple centers in the US, Europe and Australia. This is a strong manifestation of our broad, late-stage development program," said Mai-Britt Zocca, Ph.D., President and CEO IO Biotech. "Executing this clinical trial builds on IO Biotech's recent momentum including financial, international, and organizational expansion." In a Phase 1/2 clinical trial of 30 patients with metastatic melanoma, IO102-IO103, in combination with an anti-PD1 mAb, induced meaningful tumor regression and established durable antitumor response with a manageable tolerability profile for patients. In this study, there was an overall response rate of 80% and a complete response rate of 43%. Grade 3-4 adverse events were seen in 13% of patients. Based on the results from this trial, IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation, BTD, by the U.S. Food and Drug Administration, FDA, for treatment of unresectable/metastatic melanoma.