Source – Johnson & Johnson
In 2021, Johnson & Johnson’s Rybrevant received accelerated approval from the FDA, becoming the first treatment option for a specific subset of non-small cell lung cancer (NSCLC). Now, following a positive clinical trial outcome, the company aims to obtain full approval and expand the drug’s use to newly diagnosed patients.
In a recent announcement, J&J revealed that when used in conjunction with chemotherapy, Rybrevant significantly delayed cancer progression or death compared to chemotherapy alone in patients with newly diagnosed NSCLC with EGFR exon20 insertion mutations. This positive result emerged from the Phase III PAPILLON study, which also served as the confirmatory trial for Rybrevant’s accelerated approval as a second-line treatment for the same NSCLC subset.
Though J&J did not provide specific details about Rybrevant’s impact on overall patient survival at this stage, they confirmed that the safety profile of the Rybrevant-chemo combination remained consistent with that of the individual components.
Rybrevant is an infusion that competes with Takeda’s oral Exkivity in treating EGFR exon20 insertion-positive NSCLC. According to Takeda, the two drugs are sharing the US market approximately 50-50 in the second-line setting. Exkivity was introduced four months after Rybrevant and generated sales of JPY 3.2 billion ($21.5 million) in the US in the 12 months leading up to March.
Takeda’s Exkivity is also undergoing a Phase III trial in the first-line setting, with data expected to be released later as the company targets a potential filing during its fiscal year ending in March 2025. Unlike Rybrevant, Exkivity is being studied as a single agent in the first-line trial.
For Rybrevant, J&J is eagerly awaiting the results of another crucial Phase III trial, which could potentially expand the use of this bispecific antibody drug beyond the exon20 NSCLC subset.
In the Phase III MARIPOSA trial, Rybrevant, in combination with Yuhan-partnered lazertinib, is being compared to AstraZeneca’s EGFR inhibitor Tagrisso in front-line NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Lazertinib, a third-generation EGFR inhibitor, obtained its first approval in Korea in 2021 under the brand name Leclaza for previously treated, EGFR T790M mutation-positive NSCLC.
“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 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 EGFRmutated non-small cell lung cancer.”
– Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.
