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

PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission

“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the

The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from

“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is