A Major Breakthrough in Metastatic Head and Neck Cancer: Amivantamab (Rybrevant FASPRO) Shows Pivotal Results at ASCO 2026
Yesterday (May 31, 2026), mature and highly significant data from the Phase 1b/2 OrigAMI-4 trial (Cohort 1) were presented at ASCO in Chicago. This is one of the most encouraging updates we have seen in recent years for patients with advanced/metastatic head and neck squamous cell carcinoma (HNSCC), particularly HPV-unrelated disease.
Why is this important?
Until now, after failure of platinum-based chemotherapy and immunotherapy (such as Keytruda), treatment options have been extremely limited.
Standard treatments such as Cetuximab or Paclitaxel typically achieve overall response rates (ORR) of only 10-24%, with a median progression-free survival (PFS) of approximately 3-4 months.
The prognosis is often poor, and quality of life can deteriorate rapidly.
What is Amivantamab?
Amivantamab is a bispecific antibody that simultaneously targets EGFR and MET.
These two proteins are frequently overexpressed in head and neck cancer.
The treatment is administered as a subcutaneous injection that can be given in approximately 5 minutes, compared with the lengthy intravenous infusions commonly used in hospitals.
Pivotal Results (n=102 patients, median follow-up 11.8 months)
- ORR by independent central review (BICR): 42% (95% CI: 32-52)
- ORR by investigator assessment: 47% (95% CI: 37-57)
- Complete Response (CR): 15% of patients achieved complete disappearance of their tumors
- Tumor shrinkage: 79% of patients
- Median time to response: only 6.6 weeks
- Duration of response: median not yet reached; 56% of responses lasted 6 months or longer
- Median PFS: 6.8 months
- Median Overall Survival (OS): 12.5 months
- Clinical Benefit Rate: 63%
Compared with historical outcomes, these results represent a meaningful improvement in a very challenging patient population.
Safety and Tolerability
Most side effects were Grade 1–2 and included:
- Rash
- Dermatitis
- Fatigue
- Hypoalbuminemia
- Paronychia
Treatment discontinuation due to adverse events occurred in only 6–8% of patients.
Administration-related reactions occurred in 13% of patients and were all mild.
The safety profile was consistent with what has already been observed in lung cancer.
What Does This Mean for Patients?
This represents new hope rather than another “there is nothing left to do.”
Rapid tumor shrinkage may significantly improve symptoms such as:
- Pain
- Difficulty swallowing
- Breathing difficulties
The treatment is relatively convenient and may help preserve quality of life.
The data have already led to FDA Breakthrough Therapy Designation, and regulatory submissions are advancing.
The trial (NCT06385080) is ongoing, and additional cohorts are evaluating combinations with Pembrolizumab and other therapies, including first-line settings.
If You or Someone You Know Is in a Similar Situation
If you, a family member, or a patient you are supporting has advanced/metastatic HPV-negative head and neck cancer after chemotherapy and immunotherapy, contact us.
There may still be additional options worth exploring.
We can evaluate:
- Eligibility for this treatment
- Relevant clinical trials worldwide
- Compassionate use and expanded access opportunities
This is what I do every day: searching, analyzing, and matching patients with innovative treatment opportunities.
For more information:
https://trial-in.com/he/בית/
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