The FDA has granted priority review to subcutaneous amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck cancer.
The FDA has granted priority review to the supplemental biologics license application (sBLA) for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) in adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.1
The designation was supported by results from the pivotal phase 1b/2 OrigAMI-4 trial (NCT06385080), in which subcutaneous amivantamab monotherapy produced a 42% (95% CI, 32%-52%) overall response rate (ORR) in 102 patients.2 The complete response rate was 15% and the clinical benefit rate was 63% (95% CI, 53%-72%). The median duration of response (DOR) was not reached (NR; 95% CI, 6.9-NR); most patients experienced a DOR of at least 6 months (56%).
“One of the hardest things about advanced head and neck cancer is that it can impact our most basic functions, like the ability to speak, eat, and even breathe easily, profoundly affecting patients’ daily lives. For those whose disease progresses despite prior treatment, that burden is compounded by limited treatment options and poor outcomes,” Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head of oncology at Johnson & Johnson, stated in a news release.1 “Building on the established role of subcutaneous amivantamab in lung cancer, this milestone underscores its continued potential across multiple tumor types and reflects our commitment to bringing innovative treatment options to patients with cancers driven by EGFR and MET pathways.”
OrigAMI-4 was an open-label study that evaluated subcutaneous amivantamab across 6 cohorts of recurrent/metastatic HNSCC treatment settings and regimens.1 Cohort 1, which supports the sBLA, evaluated subcutaneous amivantamab as monotherapy in patients who had received prior platinum-based chemotherapy and a PD-1/PD-L1 inhibitor; patients with HPV-positive oropharyngeal squamous cell carcinoma and those with prior anti-EGFR therapy were excluded.
Subcutaneous amivantamab was administered on a weekly schedule during the initial treatment period, then every 3 weeks with weight-based dosing adjustments.
The primary end point across cohorts is ORR by investigator assessment using RECIST 1.1 criteria. Secondary end points included DOR, PFS, overall survival (OS), and safety.
At a median follow-up of 11.8 months (range, 1.1-21.9), the median PFS and OS values were 6.8 months (95% CI, 5.2-8.3) and 12.5 months (95% CI, 10.2-16.8), respectively.2
In terms of safety, all patients experienced at least 1 treatment-emergent adverse effect (TEAE). Most patients (60%) had at least 1 grade 3 or higher TEAE and 39% of patients experienced a serious adverse effect. The most frequent any-grade TEAEs that were reported in at least 30% of patients were hypoalbuminemia (50%), rash (37%), acneiform dermatitis (34%), and paronychia (34%). Treatment-related adverse effects led to treatment discontinuation in 8% of patients.
