Phase 3 Trial Results With Amivantamab-vmjw Suggest Benefits for Patients With NSCLC, EGFR Mutations

New study findings announced positive results from the phase 3 PAPILLON study that assessed amivantamab-vmjw (Rybrevant, Johnson & Johnson) combined with chemotherapy (carboplatin and pemetrexed).

Non Small Cell Lung Cancer (NSCLC) in the lung tissue | Image credit: Laszlo - stock.adobe.com

The study included patients who were recently diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

NSCLC is one of the most common cancers, making up 80% to 85% of all lung cancer cases, according to the study.

“The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division,” said the study authors.

According to the study, the phase 3 trial was created to assist in approval for treatment in adults with NSCLC and EGFR mutations whose disease has continued while being on platinum-based chemotherapy or after receiving chemotherapy. The 5-year survival rate for those with this diagnosis is less than 20%.

The PAPILLON (NCT04538664) phase 3 study is the first that was conducted on this topic. It was a randomized, open-label phase 3 study to assess how safe and efficient amivantamab-vmjw would be when combined with chemotherapy, versus chemotherapy alone.

In May 2021, amivantamab-vmjw was approved by the FDA to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations when chemotherapy was not successful.

PAPILLION phase 3 successfully met its primary endpoint of improving progression-free survival (PFS) in patients who had received amivantamab-vmjw with chemotherapy, compared to chemotherapy alone. The secondary endpoint was overall response rate (ORR) after first subsequent therapy to transition to overall survival (OS).

The study also showed a positive safety profile for amivanamab-vmjw.

“The results from the PAPILLON study support the efficacy of Rybrevant plus chemotherapy in the treatment of patients with non-small cell lung cancer with exon 20 insertion mutations. Rybrevant (amivantamab- vmjw) was the first therapy approved in the relapsed/refractory setting for patients with EGFR exon 20 insertion mutations, a population that continues to experience persistent unmet medical needs. This phase 3 study is the first of several ongoing pivotal programs to read out evaluating Rybrevant-based regimens in patients with EGFR-mutated non-small cell lung cancer,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head of Oncology at Janssen Research & Development.

The study lists warnings and precautions for patients who are taking amivantamab-vmjw. These warnings include infusion related reactions, interstitial lung disease or pneumonitis, dermatologic adverse reactions, ocular toxicity, embryo fetal toxicity, and other adverse reactions.

The findings suggest amivantamab-vmjw with chemotherapy could aid patients diagnosed with NSCLC when chemotherapy alone did not benefit.

Reference:

Treatment with RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer. Johnson & Johnson. Study Article. July 17, 2023. Accessed July 20, 2023. https://www.jnj.com/treatment-with-rybrevant-amivantamab-vmjw-plus-chemotherapy-resulted-in-statistically-significant-and-clinically-meaningful-improvement-in-progression-free-survival-in-patients-with-newly-diagnosed-egfr-exon-20-insertion-mutation-positive-non-small-cell-lung-cancer.