Johnson & Johnson's under-the-skin version of amivantamab, until now cleared only for a form of lung cancer, has picked up a second indication. Under the decision announced Thursday, according to the company's release, adults can receive the drug on its own once platinum-based chemotherapy and a PD-(L)1 inhibitor have failed to halt their recurrent or metastatic head and neck squamous cell carcinoma. Oropharyngeal tumors linked to HPV fall outside the label.
The clearance rests on early-stage evidence. It draws on one cohort of OrigAMI-4, a Phase 1b/2 study without a control group. Of the 102 patients treated in that cohort, 42% saw their tumors shrink or disappear, and more than half of those responses held beyond six months, the release showed. In some patients the tumors vanished entirely.
Approvals granted on this accelerated basis are conditional. Keeping the indication may depend on OrigAMI-5, a Phase 3 study pairing the drug with carboplatin and pembrolizumab as initial treatment for recurrent or metastatic disease. Should that trial not confirm clinical benefit, the indication could be withdrawn.
Side effects so far match what doctors have seen with amivantamab in lung cancer. In the cohort, 79% of patients developed rash, 39% had serious adverse reactions and 6% had fatal ones. The antibody acts on two targets, EGFR and MET, and is given as a short injection under the skin rather than an infusion.