Lete-cel Achieves Primary Endpoint in Pivotal Trial

Elliot Norry, MD, Adaptimmune’s Chief Medical Officer: “We are thrilled to see that 42% of patients with synovial sarcoma or MRCLS responded to treatment with lete-cel, following prior treatment with currently available therapies. Responses were durable across both indications, with an overall median duration of response greater than 18 months for people with synovial sarcoma and greater than one year for MRCLS. These data underscore lete-cel’s potential to transform the lives of people with these cancers who have a poor prognosis and few treatment options. We look forward to presenting our findings at CTOS and initiating a rolling Biologics License Application for lete-cel in 2025 for the treatment of both synovial sarcoma and MRCLS, building on the potential of our sarcoma franchise.”
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