*June 2024*
The FDA has issued a complete response letter (CRL) to the biologics license application (BLA) seeking the approval of patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR mutations who previously received with 2 or more systemic therapies.1
According to an announcement from Merck, the CRL cited findings regarding an inspection of a third-party manufacturing facility. The CRL did not identify any issues regarding the efficacy or safety of patritumab deruxtecan.
“We will work closely with the FDA and the third-party manufacturer to address the feedback as quickly as possible in order to bring the first HER3-directed medicine to patients with previously-treated EGFR-mutated NSCLC,” Ken Takeshita, MD, global head of R&D at Daiichi Sankyo, stated in a news release. “We remain confident in the ability to develop this medicine to its full potential.”
The BLA was supported by data from the phase 2 HERTHENA-Lung01 trial (NCT04619004). Findings showed that in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR-directed TKI and platinum-based chemotherapy (n = 225), the HER3-targeted antibody-drug conjugate (ADC) elicited an overall response rate (ORR) of 29.8% (95% CI, 23.9%-36.2%) per blinded independent central review (BICR) assessment. One patient (0.4%) achieved a complete response, and the rates of partial response (PR), stable disease (SD), and progressive disease (PD) were 29.3%, 44.0%, and 19.1%, respectively. The disease control rate (DCR) was 73.8% (95% CI, 67.5%-79.4%).2
Furthermore, the median duration of response (DOR) was 6.4 months (95% CI, 4.9-7.8), and the 6-month DOR rate was 43.3%. The median progression-free survival (PFS) was 5.5 months (95% CI, 5.1-5.9), and the median overall survival (OS) was 11.9 months (95% CI, 11.2-13.1). Read more.
