Pull to refresh
Logo
What Changed
Following Why Sign Up
Amivantamab combination posts 77% response rate in advanced head and neck cancer

Amivantamab combination posts 77% response rate in advanced head and neck cancer

New Capabilities

The first-line triplet doubled response in HPV-unrelated disease; the FDA has granted accelerated approval to RYBREVANT FASPRO for advanced disease.

5 days ago: FDA grants accelerated approval to RYBREVANT FASPRO

Overview

Updated 2 days ago

The U.S. Food and Drug Administration granted accelerated approval on November 6 to RYBREVANT FASPRO, the subcutaneous form of amivantamab, for advanced head and neck cancer. The decision follows a 77% confirmed response rate for a first-line combination of amivantamab, pembrolizumab and carboplatin in 22 patients with HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma, reported at ESMO 2026.

The approval covers the later-line use that had been under Priority Review, giving patients whose cancer progressed after platinum chemotherapy and a PD-1/PD-L1 inhibitor a targeted option. A Phase 3 trial, OrigAMI-5, is still testing the first-line triplet against standard chemoimmunotherapy in HPV-unrelated disease.

Why it matters

The approval gives patients whose head and neck cancer returned after standard treatment a new targeted option.

Questions about this story

Free account needed to ask — your question is kept and asked for you right after sign-up. Answers are public.

No questions yet — be the first to ask.

Key Indicators

77%
Overall response rate in HPV-unrelated HNSCC
Confirmed responses in 17 of 22 evaluable patients, including 14% complete responses.
36%
Response rate of standard pembrolizumab plus chemotherapy
The first-line benchmark the new combination is measured against, per trial investigators.
65%
Responses ongoing at median 10.6-month follow-up
11 of 17 responders continued to show tumor shrinkage or stable disease at analysis.
22
Evaluable patients with HPV-unrelated disease
Cohort 5 of the Phase 1b/2 OrigAMI-4 study; 30 patients were dosed and 29 were included in the efficacy analysis.
80–90%
HNSCC tumors where EGFR and MET drive growth and resistance
Johnson & Johnson describes both pathways as key drivers of tumor growth and resistance in 80% to 90% of these cancers.
Nov 6, 2026
FDA accelerated approval
Accelerated approval for RYBREVANT FASPRO in advanced head and neck cancer.

Voices

Curated perspectives — historical figures and your fellow readers.

Sign up to generate historical perspectives on this story.

Log in Sign Up

People Involved

ICR and Royal Marsden investigator team
ICR and Royal Marsden investigator team
Trial investigators at one of 56 OrigAMI-4 sites across 11 countries
Contributing trial center; presenting co-authors at ESMO 2026
PM
Paul L. Swiecicki, MD
Clinical associate professor, Division of Hematology/Oncology, University of Michigan Rogel Cancer Center
Commented on the Cohort 5 results and the OrigAMI-5 Phase 3 design on October 26, 2026

Organizations Involved

Johnson & Johnson
Johnson & Johnson
Pharmaceutical company
Developer of RYBREVANT FASPRO; FDA granted accelerated approval for advanced head and neck cancer on November 6, 2026; Phase 3 OrigAMI-5 ongoing

The company developing and testing amivantamab across head and neck cancer and lung cancer settings.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Granted accelerated approval to RYBREVANT FASPRO for advanced head and neck cancer on November 6, 2026

The U.S. regulator deciding whether subcutaneous amivantamab can be marketed for head and neck cancer.
TI
The Institute of Cancer Research, London
Research institution and NHS cancer center
Trial collaborator and presenter of Cohort 5 results

One of the international centers running the OrigAMI-4 trial in recurrent or metastatic head and neck cancer.
HT
Halozyme Therapeutics
Biotechnology company
Provides the ENHANZE drug-delivery technology used in RYBREVANT FASPRO; announced the FDA accelerated approval on November 6, 2026

The company whose ENHANZE technology is co-formulated with amivantamab for subcutaneous administration.

Timeline

2025 November 2026

5 events Latest: 5 days ago
Tap a bar to jump to that date

  1. FDA grants accelerated approval to RYBREVANT FASPRO

    Latest Regulatory

    Accelerated approval covers advanced head and neck cancer, clearing the later-line application that had been under Priority Review.

  2. First-line combination posts 77% ORR at ESMO 2026

    Data release

    Amivantamab plus pembrolizumab and carboplatin shows 77% confirmed response rate in HPV-unrelated HNSCC, with 65% of responses ongoing.

  3. Monotherapy response data confirmed

    Data release

    Independent review confirmed 42% ORR with 15% complete responses in pretreated metastatic HNSCC patients.

  4. FDA grants Breakthrough Therapy Designation

    Regulatory

    Designation covers amivantamab monotherapy in HPV-unrelated recurrent or metastatic HNSCC after prior platinum and immunotherapy.

  5. Monotherapy data presented at ESMO 2025

    Data release

    OrigAMI-4 Cohort 1 showed rapid, durable responses with single-agent amivantamab in heavily pretreated HNSCC patients.

Scenarios

1

FDA approves amivantamab monotherapy for later-line head and neck cancer

Likely Resolves by Q2 2027

Discussed by: Johnson & Johnson press materials citing the application under Priority Review

The FDA granted accelerated approval to RYBREVANT FASPRO for advanced head and neck cancer on November 6, 2026, clearing the later-line application that had been under Priority Review. The approval gives patients who progressed after platinum chemotherapy and a PD-1/PD-L1 inhibitor a targeted option.

2

Phase 3 OrigAMI-5 confirms the first-line benefit

Possible Resolves by End of 2028

Discussed by: ICR London and Royal Marsden investigators who advocated moving the regimen forward

OrigAMI-5 is comparing amivantamab plus pembrolizumab and carboplatin against the standard of pembrolizumab, a platinum drug, and fluorouracil in first-line HPV-unrelated disease. If the 77% response rate holds across a larger population and the trial meets its survival or progression-free survival endpoint, the combination could replace the current standard of care in the first-line setting.

3

Phase 3 trial fails to confirm the early signal

Unlikely Resolves by End of 2028

Discussed by: Trial observers noting the 77% figure rests on just 22 patients

Response rates from small cohorts often fall as trials broaden to larger, more diverse populations. If OrigAMI-5 misses its endpoint, the first-line program stalls and the combination remains unproven outside the original Cohort 5 group, while the later-line monotherapy application and any approved use would be unaffected.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

2006

Cetuximab (Erbitux) approval for head and neck cancer (2006)

The FDA approved cetuximab, the first EGFR-blocking antibody, for head and neck cancer in 2006. It showed modest response rates when used alone in recurrent or metastatic disease, and its main benefit came as an addition to radiation or chemotherapy.

Then

Cetuximab became a standard addition to radiation and chemo for locally advanced disease, but single-pathway blockade left most patients without a response.

Now

The drug proved the EGFR pathway is a valid target in HNSCC, setting the stage for combination approaches.

Why this matters now

Amivantamab also blocks EGFR but adds a second target, MET, aiming to overcome the resistance that limited single-pathway drugs like cetuximab.

2019

KEYNOTE-048 trial (2019)

The KEYNOTE-048 trial established pembrolizumab plus chemotherapy as the first-line standard for recurrent or metastatic head and neck squamous cell carcinoma. It reported an objective response rate around 36% and improved overall survival in PD-L1-positive tumors.

Then

Pembrolizumab plus chemo became the global first-line benchmark for this patient group.

Now

The roughly 36% response rate has stood as the bar newer regimens must clear.

Why this matters now

The amivantamab combination's 77% response rate is measured against this pembrolizumab-plus-chemo benchmark in the same first-line setting.

2021–2024

Amivantamab in EGFR-mutated lung cancer (2021–2024)

Amivantamab was first approved in May 2021 for EGFR-mutated non-small cell lung cancer, and later trials including MARIPOSA validated its dual EGFR-MET targeting in earlier treatment lines.

Then

The drug became a standard option across lung cancer settings, building a safety and efficacy record in thousands of patients.

Now

The same dual-targeting mechanism is now being carried into head and neck cancer, where EGFR and MET are overexpressed in most tumors.

Why this matters now

Amivantamab's lung cancer approvals are the foundation the HNSCC program draws on, giving regulators and investigators years of real-world data.

Sources

(9)
+3
PR Newswire via StreetInsider The Institute of Cancer Research, London Johnson & Johnson Investor Relations Johnson & Johnson Healio OncLive Johnson & Johnson OncLive PR Newswire