Johnson & Johnson reports response rate for head, neck cancer treatment

Johnson & Johnson (JNJ) reported that its cancer drug Rybrevant Faspro, combined with immunotherapy and chemotherapy, shrank tumors in 77% of patients with certain forms of advanced head and neck cancer in an early-stage clinical trial. The findings were presented at the European Society for Medical Oncology's 2026 congress in Madrid.

The Phase 1b/2 OrigAMI-4 study evaluated Rybrevant Faspro alongside pembrolizumab, marketed as Keytruda by Merck (MRK), and the chemotherapy drug carboplatin. Among 22 patients with recurrent or metastatic head and neck squamous cell carcinoma, excluding a form of throat cancer associated with human papillomavirus, 77% experienced a confirmed reduction in tumor size. About 14% had a complete response, meaning their detectable tumors disappeared. All evaluable patients in this group experienced some tumor shrinkage.

Responses occurred after a median of 9.4 weeks, and 65% remained ongoing after a median follow-up of 10.6 months. At one year, 77% of patients were alive, although the study was not designed to establish a survival advantage over existing treatments. Results were less encouraging among seven patients with HPV-associated oropharyngeal cancer, whose response rate was 29%.

For investors, the findings support Johnson & Johnson's (JNJ) efforts to expand Rybrevant Faspro beyond its existing lung cancer indications into the market for head and neck cancer treatments. The company is already conducting a larger Phase 3 trial, OrigAMI-5, to evaluate the drug in this setting. However, the latest results come from a small, early-stage study without a randomized comparison group, leaving its potential advantages over established therapies unproven.

Rybrevant Faspro is a bispecific antibody, an engineered protein designed to target two proteins involved in cancer growth, EGFR and MET. These proteins help transmit signals that encourage cells to multiply and can contribute to resistance against cancer treatments. Blocking both pathways may interfere with tumor growth while helping the immune system attack cancer cells. The drug is administered by injection under the skin, rather than through an intravenous infusion, with administration taking five minutes or less.

The most common side effects included anemia, or low red blood cell counts, in 73% of patients; low levels of albumin, a blood protein, in 63%; reduced platelets, which help blood clot, in 63%; and inflammation of the mouth in 57%. Injection-related reactions occurred in 13% of patients, with no severe reactions reported.

Rybrevant Faspro received FDA approval in December 2025 for certain forms of non-small cell lung cancer involving EGFR mutations. Johnson & Johnson (JNJ) is also seeking approval for its use in previously treated head and neck cancer, with that application currently under priority review by the FDA. The latest findings could broaden the drug's commercial potential if larger studies confirm its effectiveness and safety.