New Treatment for Head and Neck Cancer Shows Promising Response Rates

Promising Results from RYBREVANT FASPRO™ in Head and Neck Cancer

In a recent announcement, Johnson & Johnson (NYSE:JNJ) introduced compelling findings from the Phase 1b/2 OrigAMI-4 study regarding their investigational treatment, RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). This treatment, evaluated in combination with a PD-1 inhibitor, demonstrated a notable overall response rate of 56% among patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The results were presented at the 2026 Multidisciplinary Head and Neck Cancers Symposium, emphasizing the evolving landscape of cancer treatment.

Understanding Head and Neck Cancer Challenges

Head and neck squamous cell carcinoma, an aggressive form of cancer, poses significant treatment challenges. Patients frequently face the recurrence or spread of the disease post-diagnosis, with current standard treatments, including PD-1 monotherapy achieving only an approximate 18% response rate. This limited effectiveness has highlighted the urgent need for more robust therapeutic options.

As per the results from the OrigAMI-4 study, the RYBREVANT FASPRO™ regimen was administered in a combination therapy format to patients who had not received any prior treatments for their advanced disease. Among the 39 patients assessed in this cohort, 22 experienced a confirmed overall response, encompassing six patients achieving complete responses, an encouraging outcome for this tough-to-treat cancer type.

A Closer Look at the Findings

The study indicated that a remarkable 82% of evaluated patients exhibited tumor shrinkage, while 74% achieved either a confirmed response or stable disease. What sets this treatment apart is not only the high response rate but also its rapid action, with patients witnessing responses as early as 9.7 weeks after the onset of treatment. Furthermore, the durability of treatment was notable, with a significant 46% of patients remaining on therapy at the median follow-up of 10.4 months.

An important aspect of this combined regimen is its targeting of critical pathways involved in tumor growth and treatment resistance, a strategy that could potentially redefine future treatment standards in HNSCC. Leading oncologists, including Dr. Ranee Mehra from the Marlene and Stewart Greenebaum Comprehensive Cancer Center, have highlighted the importance of rapid and sustained disease control in head and neck cancer, viewed as a key metric in assessing new therapies.

Safety Profile and Continued Research

The safety profile observed in patients undergoing treatment with subcutaneous amivantamab and pembrolizumab was aligned with previous findings associated with the individual therapies. Among adverse events reported, the majority were manageable, with common occurrences including rash, nail toxicity, and fatigue. Importantly, none of the side effects escalated to Grade 3 or higher severity in more than 15% of the patients, reinforcing the therapeutic potential of this approach without the heightened risk of severe adverse reactions.

As the understanding of the mechanisms driving HNSCC evolves, so does the potential for new treatments that address both resistance and tumor growth pathways. As noted by Joshua Bauml, Vice President at Johnson & Johnson, the rapid and durable disease control exhibited opens doors to redefine expectations and therapeutic heights in this challenging arena.

The promising outcomes from the OrigAMI-4 study ensure that further evaluations of RYBREVANT FASPRO™ are necessary. The ongoing Phase 3 OrigAMI-5 study aims to assess its effectiveness further, showcasing its adaptability in conjunction with other therapies for patients with significant unmet needs.

Conclusion

The announcement from Johnson & Johnson on RYBREVANT FASPRO™ reflects a potential pivotal advancement in the management of recurrent or metastatic head and neck cancer. The 56% overall response rate not only surpasses existing treatment standards but also marks a crucial shift towards more effective and comprehensive cancer care. Ongoing studies will continue to explore this innovative approach, focusing on its long-term impacts and integrations into regular treatment protocols.

For more information on RYBREVANT FASPRO™ and ongoing clinical trials, visit RYBREVANT.com.