Alignment with FDA obtained on 80 mg QD as RP3D and on the 2L+ patient population for the ENABLE-2 pivotal trial of ELVN-001 in CML patients
“These promising results continue to showcase the consistency of ELVN-001’s overall profile and reinforce its potential to be a best-in-class ATP-competitive inhibitor with differentiated activity relative to allosteric inhibitors,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “In these data, we observed higher response rates in patients treated in earlier lines of therapy, and comparable response rates regardless of prior asciminib exposure. We are also thrilled by the outcome of our recent End-of-Phase 1 meeting with the FDA, where we reached alignment on the 80 mg once daily dose and the inclusion of patients who have received at least one prior TKI in the planned ENABLE-2 Phase 3 trial. This is an important milestone as we advance towards initiating ENABLE-2 later this year.”
Share:
More News
Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: “The dosing of patients marks an important milestone for Anocca, and demonstrates our ability to develop, manufacture and clinically deploy precision TCR-T cell therapy products. The novel ANOC-001 clinical candidate was developed with Anocca’s proprietary analytical platform that maps targets
“The clinical experience in 81 patients validates both EBTATE and the broader Evans Blue platform,” said Chris Pak, Chairman and Chief Executive Officer of MTTI. “By improving tumor delivery and retention while requiring only approximately 12.5% of the cumulative radioactivity administered in current standard-of-care PRRT, the platform has the potential
Leslie Chong, Managing Director and CEO of Imugene, commented: “FDA Fast Track Designation for both CLL/SLL and MZL reflects the meaningful clinical activity we are seeing with azer-cel across multiple B-cell malignancies. For patients who have exhausted standard treatment options in these indications, we believe azer-cel represents a genuinely promising
“Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered,” said Olivier Nataf, Global Head of Oncology at Sanofi. “Sarclisa, which has been prescribed to nearly 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the