PALOMA-2 Reinforces Efficacy of SubQ Amivantamab in EGFR-Mutated NSCLC: Sun Lim Min, MD, PhD

The safety and efficacy of first-line subcutaneous amivantamab plus chemotherapy for patients with EGFR exon 20 insertion–mutated advanced non–small cell lung cancer is similar to that seen in the PAPILLON study, explained Sun Min Lim, MD, PhD, of the Division of Medical Oncology in the Department of Internal Medicine at Yonsei University College of Medicine in Seoul, South Korea.

Lim presented the results of the study into the new subcutaneous formulation of amivantamab at the 2025 World Lung Cancer Conference, held September 6 to September 9, 2025, in Barcelona, Spain.

Transcript

Can you summarize the key findings from the PALOMA-2 exon 20 study and how they build on prior research?

The PALOMA-2 study is a phase 2 bridging study that evaluates the subcutaneous amivantamab plus chemotherapy in EGFR exon 20 insertion–mutated advanced non–small cell lung cancer patients. This study assessed the efficacy, safety, and tolerability in the exon 20 insertion cancer patients.

We know that [findings were] consistent with the pivotal data derived from the PAPILLON study— we saw the consistent efficacy and safety profiles. The primary end point of this study was the objective response rate assessed by the investigator. In this study of 66 patients and the objective response rate was 76%. The clinical benefit rate was 94%, and the median time to response was within 2 months. At the time of data cutoff, most patients [had ongoing response]. These [findings] are very similar [and] consistent with the PAPILLON study results.

How do the progression-free survival and overall survival results compare with currently available options for this patient population?

At the time of data cutoff, the median follow-up duration was just over 10 months, and the median progression-free survival was 12.2 months, and the median overall survival was not estimable at the time of data cutoff. These were the patients who had no therapeutic options except for the amivantamab. However, consistent with the PAPILLON study, subcutaneous amivantamab, in combination with chemotherapy, showed that the clinical benefit was durable and was maintainable for these patients.