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
“This positive opinion from the CHMP highlights the significant unmet need and importance of effective treatment options for adult r/r B-ALL,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “With FDA approval received in November 2024 and an MHRA conditional marketing authorization received in April 2025, we are on
“While we are disappointed by today’s outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies,” said Liz Barrett, President and CEO of UroGen. “The FDA carefully considers the independent advice from ODAC, and we look forward to
“Columvi in combination with GemOx demonstrated a 41% reduction in risk of death in a Phase III, randomized, multiregional clinical trial, supporting its recent approval by the European Commission and inclusion in the U.S. National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen,” said Levi Garraway, M.D.,
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “Today’s approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL
