New study yields positive results for combination therapy in newly diagnosed exon 20 patient population

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The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced promising results from its phase 3 PAPILLON study for Rybrevant (amivantamab-vmjw). The confirmatory study sought to evaluate Rybrevant treatment when combined with chemotherapy (carboplatin-pemetrexed) in a specific patient population with outstanding medical needs. 

Researchers assessed the compound treatment in adult patients who were newly diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. This is the first late-stage clinical program for Rybrevant and the first randomized study to demonstrate statistically significant and clinically meaningful results.

The PAPILLON phase 3 study met its primary endpoint by demonstrating progression-free survival (PFS) in patients who received both Rybrevant and chemotherapy compared to those who received only chemotherapy. The safety and efficacy profiles of the study were in line with those of the treatments when administered individually.  

“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,” said Peter Lebowitz, MD, PhD, global therapeutic area head of oncology, at Janssen Research & Development, LLC. “This phase 3 study is the first of several ongoing pivotal programs to read out evaluating Rybrevant-based regimens in patients with EGFR-mutated non-small cell lung cancer.”

Janssen looks to present the published results at an upcoming scientific congress and continues to seek approval of the two-part treatment in patients who have onset advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy alone.  

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