FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial for non-small cell lung cancer (NSCLC). MSD’s chief medical officer (CMO) has sounded a note of caution for Akeso and Summit, emphasizing that an improvement in overall survival (OS) will likely be necessary for future FDA approval in the U.S. Additionally, there are concerns regarding the trial’s location and the choice of comparator treatment in the study design.
As reported earlier, Akeso and Summit announced data from the China-only Phase III HARMONi-2 trial, which assessed ivonescimab as a monotherapy first-line treatment in 398 NSCLC patients with PD-L1 expressing tumors, compared head-to-head with Keytruda monotherapy. The trial met its primary endpoint, showing significant improvement in progression-free survival (PFS) in both high- and low-PD-L1 expressing tumors, with no comments on overall survival (OS).
Speaking from the sidelines of the American Society of Clinical Oncology (ASCO) annual meeting, Merck Research Laboratories’ CMO Dr. Eliav Barr acknowledged the trial as “Good news for patients or maybe another [treatment] option.” However, he also noted that the full data set, including OS details, will be closely watched: “Patients, regulators, payers […] will focus on OS.” MSD has experimented with Keytruda in combination with various VEGF inhibitors, but as Barr pointed out, “In many of our studies, PFS was positive, including in lung. But [overall survival] was a little more difficult to show.”
Barr also commented on the choice of Keytruda as a monotherapy, suggesting it may be insufficient for approval. While Keytruda was initially approved as a standalone therapy for first-line NSCLC in 2016, it is now typically used in combination with chemotherapy for cases with a lower PD-L1 expression, meaning ivonescimab will need to be assessed against Keytruda in combination with chemo.
Commenting on the Akeso/Summit ivonescimab data, Dr. Richard Pazdur, the U.S. FDA’s oncology chief, stated during an ASCO 2024 side meeting that a China-only study is unlikely to be sufficient for FDA review due to the inability to assess all trial sites and the lack of ethnic diversity in the patient population.- Flcube.com
