First Patient Dosed in Global Randomized Ph 3 Study (INVINCIBLE-3) in Metastatic Soft Tissue Sarcoma

“We have now dosed our first patient in the U.S. and have filed regulatory documents to initiate this trial in Canada and Europe. Over the next several months, we anticipate initiating sites in eight countries. Sarcoma is a deadly cancer with a median overall survival following second and third-line drug treatments of between 10 and 15 months,” said Intensity Therapeutics’ Founder, Chairman, and CEO, Lewis H. Bender. “During our phase 1/2 metastatic dose escalation study, in a sarcoma population that had progressed following a median of 3 lines of therapy, we reported a median overall survival of 21.3 months with our drug alone. Patients, their caregivers, and physicians worldwide desperately need improved treatment options and we are excited to have finally begun testing our new approach in Phase 3. I want to take this opportunity to thank our dedicated team for getting us to this tremendous milestone.”
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