An FDA accelerated approval in 2021 made Johnson & Johnson’s Rybrevant the first treatment for a specific subset of non-small cell lung cancer (NSCLC). Now, with a positive clinical trial readout, the company hopes to win a full approval and extend the drug to newly diagnosed patients.
Rybrevant, used on top of chemotherapy, significantly delayed cancer progression or death compared with chemo alone in patients with newly diagnosed NSCLC with EGFR exon20 insertion mutations, J&J said Monday.
The progression-free survival win comes from the phase 3 PAPILLON study, which also serves as the confirmatory trial for Rybrevant’s accelerated approval as a second-line treatment in the same NSCLC subset.
In its Monday release, J&J didn’t describe how Rybrevant fared in terms of extending patient survival at this point but said the safety profile of the Rybrevant-chemo combo was consistent with those of the two components.
Rybrevant, which is an infusion, competes with Takeda’s oral Exkivity in EGFR exon20 insertion-positive NSCLC. The two drugs are splitting the U.S. market roughly 50-50 in the second-line setting, according to Takeda. Arriving four months behind Rybrevant, Exkivity sold JPY 3.2 billion ($21.5 million) in the U.S. during the 12 months that ended this March.
Exkivity’s own phase 3 trial in the first-line setting reads out later as Takeda is targeting a potential filing during its fiscal year ending in March 2025, which is a little behind the company’s original plan. Instead of a combination with chemo, Exkivity is being studied as a single agent in the first-line trial.
For Rybrevant, J&J has another important phase 3 readout that could expand the bispecific antibody drug beyond exon20 NSCLC.
The phase 3 MARIPOSA trial is pitting a pairing of Rybrevant and Yuhan-partnered lazertinib against AstraZeneca’s EGFR king Tagrisso in front-line NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Lazertinib, a third-generation EGFR inhibitor, got its first approval in Korea in 2021 under the brand name Leclaza for previously treated, EGFR T790M mutation-positive NSCLC.
The MARIPOSA trial has already passed a prespecified interim analysis and could report data from its final analysis later this year, J&J CFO Joseph Wolk said during an investor call in April.