New clinical data from 2L ONSEMBLE trial provides further evidence of the efficacy of onvansertib + FOLFIRI/bev in bev naïve RAS-mutated mCRC patients
“The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting. The only objective responses observed on the trial occurred in bev naïve patients who received onvansertib plus standard of care, and the combination of onvansertib with standard of care was well-tolerated. By moving our lead program to the first-line setting, all patients on the CRDF-004 trial will be bev naïve,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Importantly, no responses were observed in bev naïve patients randomized to the control arm, suggesting onvansertib improved the efficacy of standard of care therapy. And similarly, no responses were observed in patients who had received bev as part of their first line therapy in the onvansertib or the control arms, providing further evidence in a randomized setting of onvansertib’s potential to improve outcomes for patients when added to standard of care in the first-line setting. We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024.”
Share:
More News
“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,
“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to
“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look
“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are
