Melina E. Marmarelis, MD, reports the safety and efficacy data from the phase 1 CHRYSALIS-2 trial.
Melina E. Marmarelis, MD, assistant professor of Medicine at the Hospital of the University of Pennsylvania, reports the safety and efficacy data from the phase 1 CHRYSALIS-2 trial (NCT04077463).
Patients with EGFR-mutant non–small cell lung cancer in the CHRYSALIS-2 study were treated with the combination of amivantamab-vmjw (Rybrevant), lazertinib (Leclaza), and carboplatin and pemetrexed. Encouraging responses were observed with the treatment. The objective response rate was 50% (95% CI, 27%-73%) with a clinical benefit rate (CBR) of 80% (95% CI, 56%-94%) in the general population.
Among patients with baseline brain metastases, the ORR was 50% (95% CI, 19%-81%) with a CBR pf 80% (95% CI, 44%-98%).
According to Marmarelis, 15 out of 20 patients were still on treatment with an additional follow-up of 7 months. Of the patients continuing treatment, 10 previously achieved a partial response.
0:08 | The primary efficacy endpoint was discussed, and the safety signals were as previously reported for amivantamab, lazeritinib, and chemotherapy on their own. There was a slightly higher numerical rate of cytopenias seen, in particular, neutropenia in the first cycle. And this it's difficult to interpret based on the heterogeneous group of patients that had received also previous chemotherapy. Also, the fact that it was checked in between cycles, which is not standard clinical practice, may have elevated those numbers slightly. But in general, there were no new safety signals for this combination.
0:47 | In terms of efficacy, we did see an overall response rate of 50% and a clinical benefit rate of 80%. And that was seen regardless of whether patients had baseline brain metastases or not. The other important finding is that with a median follow up of seven months, we did see that 15 out of 20 patients were still on treatment, and 10 out of the 10 patients that had a partial response remained on treatment at the time of data cut off, suggesting that we are seeing some durable responses with this combination.