Genmab might have hit a snag with its pivotal, open-label Liger-HN1 trial, which was recently brought into its pipeline via the $8bn acquisition of Merus. The study, evaluating its anti-EGFR x Lgr5 bispecific antibody petosemtamab plus Keytruda in first-line, PD-L1-positive head and neck cancer, has undergone notable changes, including a protocol update increasing the enrolment target from 500 to 700 patients, a remarkable 40% jump. One possible reason for this could be that emerging case reports aren't strong enough, and the company needs to increase the trial's statistical powering. It's not clear what HPV profile the expansion mandates in the extra patients, but it's notable that Genmab has so far positioned petosemtamab as being active in HPV-negative and positive disease, despite the backing for the latter coming from just eight patients' worth of data; among these a 50% response rate has been claimed. Activity in HPV-positive disease is a key differentiator versus Bicara’s rival project ficerafusp alfa, which focuses exclusively on HPV-negatives in the same indication. By comparison, ficerafusp, in a first-line combo with Keytruda, notched a 54% ORR in 39 patients, but responses were primarily observed in HPV-negative disease; the implied ORR in 11 HPV-positive patients was just 27%.
Genmab might have hit a snag with its pivotal, open-label Liger-HN1 trial, which was recently brought into its pipeline via the $8bn acquisition of Merus. The study, evaluating its anti-EGFR x Lgr5 bispecific antibody petosemtamab plus Keytruda in first-line, PD-L1-positive head and neck cancer, has undergone notable changes, including a protocol update increasing the enrolment target from 500 to 700 patients, a remarkable 40% jump. One possible reason for this could be that emerging case reports aren't strong enough, and the company needs to increase the trial's statistical powering. It's not clear what HPV profile the expansion mandates in the extra patients, but it's notable that Genmab has so far positioned petosemtamab as being active in HPV-negative and positive disease, despite the backing for the latter coming from just eight patients' worth of data; among these a 50% response rate has been claimed. Activity in HPV-positive disease is a key differentiator versus Bicara’s rival project ficerafusp alfa, which focuses exclusively on HPV-negatives in the same indication. By comparison, ficerafusp, in a first-line combo with Keytruda, notched a 54% ORR in 39 patients, but responses were primarily observed in HPV-negative disease; the implied ORR in 11 HPV-positive patients was just 27%.
