The CHRYSALIS-2 study cohort evaluated the safety and tolerability of the combination of Rybrevant with Lazertinib plus platinum-based chemotherapy in patients with relapsed/refractory NSCLC and EGFR mutations
Treatment with Rybrevant and lazertinib plus chemotherapy delivered durable PFS in the trial. (Credit: valelopardo from Pixabay)
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the combination of Rybrevant (amivantamab-vmjw), lazertinib, and chemotherapy has shown durable progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients in a cohort of the Phase 1b/2 CHRYSALIS-2 study.
Rybrevant is a bispecific antibody that targets epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET). Lazertinib, on the other hand, is an oral third-generation EGFR tyrosine kinase inhibitor (TKI).
The CHRYSALIS-2 study cohort assessed the safety and tolerability of the combination of Rybrevant with Lazertinib plus platinum-based chemotherapy (carboplatin and pemetrexed) in 20 patients with relapsed/refractory NSCLC and EGFR mutations.
In the trial, the combination of Rybrevant and lazertinib with chemotherapy had an objective response rate of 50%, with 11 out of 20 patients still receiving treatment.
The median duration of response was not met after a median follow-up of 13.1 months.
According to Johnson & Johnson, the median PFS was 14 months. The company said that eight out of 10 respondents had a minimum six-month response period.
Furthermore, five patients received treatment beyond progression with a median incremental treatment time of 4.2 months.
Janssen Research & Development solid tumours clinical development vice president Kiran Patel said: “The strong anti-tumour activity of Rybrevant in EGFR-driven cancers reinforces the utility of this targeted, bispecific therapy in patients whose tumours are resistant.
“These results provide important insights into the treatment of patients with advanced non-small cell lung cancer with EGFR-mutated disease who have progressed on the current standard of care. We look forward to upcoming late-stage Phase 3 study readouts.”
CHRYSALIS-2, which is an open-label study that assessed the safety and pharmacokinetics of lazertinib as monotherapy or in combination with Rybrevant. Overall, the study recruited 460 advanced NSCLC patients.
In May 2021, Rybrevant secured accelerated approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
Recently, Janssen announced that a combination therapy involving Rybrevant met the dual primary endpoint in a three-arm Phase 3 MARIPOSA-2 study in certain lung cancer patients.