强生OrigAMI-4头颈癌Ib/II期数据获阳性结果，但该催化已重复传播且财务弹性不足

Johnson & Johnson (JNJ) announced new results from Cohort 5 of the Phase 1b/2 OrigAMI-4 study demonstrating deep and durable responses, with 65% remaining ongoing at the clinical cut-off with first-line subcutaneous amivantamab and hyaluronidase-lpuj plus a PD-1 inhibitor and fixed-duration carboplatin chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Head and neck squamous cell carcinoma (HNSCC) is the most common type of head and neck cancer, arising in tissues of the mouth, throat, larynx, sinuses, nasal cavity and salivary glands.
Subcutaneous amivantamab is a bispecific antibody that targets both EGFR and MET while engaging the immune system.
OrigAMI-4 Trial Details
OrigAMI-4 is an open-label Phase 1b/2 trial evaluating RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study comprises six cohorts investigating the therapy across multiple treatment settings and combination regimens.
Cohort 5 of the OrigAMI-4 study evaluated subcutaneous amivantamab in combination with pembrolizumab (PD-1 inhibitor) and up to six cycles of carboplatin in previously untreated patients with recurrent or metastatic HNSCC.
Patients received treatment every three weeks after the initial treatment period.
The primary endpoint was investigator-assessed ORR per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) criteria. Given known differences in responsiveness to EGFR-targeted bispecific therapies, the company evaluated efficacy separately in patients with HPV-associated OPSCC (n=7) and other forms of HNSCC (n=22).
Thirty patients received subcutaneous amivantamab plus pembrolizumab and carboplatin, with 29 included in the efficacy analysis after one patient was deemed ineligible.
Key Findings
The findings presented in a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 include the following.
According to the company, in 22 patients with non-HPV-associated HNSCC, the confirmed overall response rate (ORR) was 77%, including complete responses in 14% of patients and partial responses in 64%. Median overall survival was not reached, with 77% of patients alive at one year. In HPV-associated OPSCC patients (n=7), the ORR was 29%.
All evaluable patients experienced tumour shrinkage. Responses occurred within a median of 9.4 weeks, with 65% remaining ongoing at a median follow-up of 10.6 months.
The safety profile of subcutaneous amivantamab combined with pembrolizumab and carboplatin was consistent with that of the individual agents.
The most common adverse events were anaemia (73%), hypoalbuminemia (63%), thrombocytopenia (63%), and stomatitis (57%), the company said.
Road Ahead
The results support the continued evaluation of the investigational RYBREVANT FASPRO regimen in an ongoing first-line Phase 3 study.
RYBREVANT FASPRO is approved in the U.S. and several international markets for the treatment of adults with EGFR-mutated NSCLC, including exon 19 deletion, exon 21 L858R, and exon 20 insertion mutations.
The FDA is currently reviewing RYBREVANT FASPRO under its Priority Review pathway for later-line head and neck cancer.
RYBREVANT-based regimens are also under investigation for several solid tumours, including head and neck and colorectal cancers.
Stock Performance
Earlier this month, the company reported third-quarter 2026 results, posting lower profit while raising its fiscal 2026 outlook.
JNJ has traded between $184.66 and $281.07 over the past 52 weeks. The stock closed Friday's trade at $263.81, down 1.42%.
In overnight trading, JNJ is up 0.14% at $264.19.
For more such biotech stock news, visit www.rttnews.com
For comments and feedback contact: editorial@rttnews.com
Business News
October 16, 2026 16:06 ET Monthly consumer price inflation data and retail sales figures were the main news from the U.S. economy this week. In Europe, monthly GDP figures from the U.K. gained attention. External trade data from China was in focus in Asia. Elsewhere, the International Monetary Fund released its latest projections for the global economy.