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Data From Phase III PALOMA-3 Study for NSCLC Presented at ASCO Show Five-Fold Reduction in Infusion-Related Reactions

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Johnson & Johnson has announced first data from the Phase III PALOMA-3 study for locally advanced or metastatic non-small cell lung cancer (NSCLC). Results of the randomized, open-label trial, evaluating subcutaneous (SC) amivantamab combined with lazertinib in patients with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R mutations showed non-inferior efficacy and pharmacokinetics (PK) for SC amivantamab combined with lazertinib compared to intravenous (IV) administration, the currently approved formulation of RYBREVANT (amivantamab-vmjw).1

These results, which are J&J’s fourth positive Phase III readout for the RYBREVANT clinical program, were featured in a presentation at ASCO 2024.

The PALOMA-3 study (NCT05388669) enrolled 418 patients. The co-primary PK endpoints were trough concentration (Ctrough on Cycle [C] 2 Day [D] 1 or C4D1) and C2 area under the curve (AUCD1-D15). Key secondary endpoints were objective response rate and progression-free survival (PFS). Overall survival (OS) was a predefined exploratory endpoint.

“The PALOMA-3 data show that subcutaneous amivantamab offers shorter infusion times and lower rates of infusion-related reactions and venous thromboembolism with pharmacokinetics and efficacy comparable to the current IV administration,” Natasha B. Leighl, BSc, MMSc, MD, medical oncologist at the Princess Margaret Cancer Centre in Toronto, Canada said in a press release. “I look forward to seeing how these findings can make a meaningful difference in clinical practice by potentially improving the treatment experience for patients with EGFR-mutated non-small cell lung cancer.”

According to the press release, at a median follow-up of seven months, results showed the overall response rate was 30% (95% confidence interval [CI], 24–37) in the subcutaneous arm and 33% (95% CI, 26–39) for IV (relative risk, 0.92; 95% CI, 0.70-1.23; P=0.001), meeting the noninferiority criteria. SC amivantamab also demonstrated longer duration of response, PFS, and significant improvement in OS compared to IV administration during this time.

Additionally, a pre-specified exploratory endpoint showed patients treated with SC amivantamab had significantly longer OS compared with IV (HR, 0.62; 95% CI, 0.42–0.92; nominal P=0.02). At 12 months, 65% of patients who received SC amivantamab combined with lazertinib were alive compared with 51% of those treated with the IV regimen.

“We are always exploring innovative approaches to meet the urgent needs of patients living with EGFR-mutated non-small cell lung cancer and these compelling findings reinforce the potential for a new route of administration for amivantamab,” Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head, oncology, Johnson & Johnson Innovative Medicine said in the press release. “We look forward to pursuing regulatory submissions for this formulation, as we advance our ambition to transform the first-line treatment of EGFR-mutated NSCLC.”


1. First results from late-breaking Phase 3 PALOMA-3 study show five-fold reduction in infusion-related reactions with five-minute subcutaneous amivantamab administration. News release. May 31, 2024. Accessed June 4, 2024.