Following Merus’ splash last month with a “best-in-disease profile” for its head and neck cancer bispecific, Bicara touted positive results for its monocolonal antibody, but analysts say Merus still has the upper hand.
Presenting at the American Society of Clinical Oncology conference in Chicago over the weekend, Bicara Therapeutics released promising results for its head and neck cancer drug ficerafusp alfa, as the company seeks to regain ground recently lost to rivals in this space—in particular, Merus, whose bispecific last month floored investors with a survival rate of nearly 80% at 12 months.
Indeed, analysts were underwhelmed by Bicara’s Phase 1/1b data, which showed a two-year overall survival (OS) rate of 46% for patients with head and neck squamous cell carcinoma (HNSCC) who were HPV-negative and treated with ficerafusp alfa in combination with Keytruda. Median OS for these patients was 21.3 months and the confirmed objective response rate (ORR) was 54%.
“Full data for Bicara’s Ficerafusp Alfa continued to look less competitive when compared to what we saw in the release of MERUS’ data two weeks ago,” BMO wrote in a note to investors early Monday morning.
Leerink Partners agreed, with analysts writing to investors, “BCAX’s ficerafusp alfa final data do not tip the scale meaningfully.”
Bicara’s share price slumped 40% last month after Merus’ announcement.
Ficerafusp alfa is a directed monoclonal antibody that targets epidermal growth factor receptors and also binds to human transforming growth factor beta. Used in patients with recurrent or metastatic forms of HNSCC, David Raben, Bicara’s chief medical officer, said the drug offers a “deeper and more durable” response.
Of the 15 patients with confirmed ORRs, 12 showed at least 80% tumor shrinkage, with a median duration of response of 21.7 months. Median progression-free survival was 9.8 months for the HPV-negative group, but this dropped to 7.4 months for all patients, which Leerink called the “more apples-to-apples comparison” with Merus’ drug, which outperformed Bicara’s in this group.
“Given that Merus had a meaningfully higher 12m OS landmark rate of 79% vs that seen with FA at 62%, we think this bodes well for peto’s eventual OS duration,” the analysts wrote. Still, the Moffitt Cancer Center’s Christine H. Chung, who has worked on Bicara-funded studies, touted the results as “impressive” in the company’s June 1 press release. “This reflects the enhanced ability of ficerafusp alfa to remodel the tumor microenvironment allowing the tumor penetration of immune cells,” she said.
Bicara also said the drug showed a “manageable” safety profile consistent with previously reported adverse events. The company is currently recruiting patients for a phase II/III trial.
Merck, which owns Keytruda, also presented HNSCC data at the Chicago meeting. It showed the IO blockbuster was more effective when given after chemoradiation than when used concurrently. And in April, Merck reported that use of Keytruda around surgery can reduce the risk of certain head and neck cancers returning.
Those data come as the FDA is due to decide this month whether to approve Keytruda as a neoadjuvant and adjuvant treatment for early stage HNSCC.
Head and neck cancer is the sixth most common cancer in the world, with almost two-thirds of patients diagnosed when they have locally advanced disease. Bicara said ficerafusp alfa could also help treat other EGFR-expressing solid tumors of squamous cell origin, such as colorectal cancer.
