4:27 PM
 | 
May 16, 2018
 |  BC Extra  |  Clinical News

First-line NSCLC data reported ahead of ASCO

Merck & Co. Inc. (NYSE:MRK), Pfizer Inc. (NYSE:PFE) and Bristol-Myers Squibb Co. (NYSE:BMY) each reported Phase III data for their first-line non-small cell lung cancer programs in abstracts released ahead of the American Society of Clinical Oncology meeting in Chicago.

Merck’s interim analysis of the first 204 patients in the Phase III KEYNOTE-407 trial to treat metastatic squamous NSCLC showed that its PD-1 inhibitor Keytruda pembrolizumab plus carboplatin/paclitaxel or Abraxane nab-paclitaxel led to an overall response rate (ORR) of 58.4% vs. 35% for carboplatin/paclitaxel or Abraxane alone at a median follow-up of 7.7 months (p=0.0004). Merck previously reported that the trial met the secondary ORR endpoint, but had not disclosed detailed data.

In its ASCO abstract, Pfizer said first-line treatment with once-daily 45 mg oral dacomitinib (PF-00299804) significantly improved median overall survival (OS) vs. Iressa gefitinib in the Phase III ARCHER 1050 trial in 452 patients with locally advanced or metastatic, EGFR mutation-positive NSCLC (34.1 vs. 26.8 months, HR=0.76, 95% CI: 0.582, 0.993, p=0.044). Dacomitinib also led to a 30-month survival rate of 56.2% vs. 46.3% for Iressa.

In April, FDA accepted and granted Priority Review to an NDA for dacomitinib to treat advanced or metastatic EGFR mutation-positive NSCLC In treatment-naïve patients. The PDUFA date is in September. The inhibitor of human EGFR, EGFR2 and EGFR4 is also under review by EMA for the same indication (see BioCentury Extra, April 4).

BMS's ASCO abstract reported new data from the Phase III CheckMate -227 trial showing that anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab significantly improved progression-free survival (PFS) vs. chemotherapy in 550 stage IV NSCLC patients with PD-L1 expression of less than 1% (HR=0.74, 95% CI: 0.58, 0.94).

The original CheckMate -227 protocol stratified patients by PD-L1 status and designated PFS in patients with PD-L1 expression of less than 1% as one co-primary endpoint and overall survival (OS) in patients with PD-L1 expression of at least 1% as the other. In February, BMS disclosed it had changed the population in which PFS was to be measured and announced that Opdivo plus Yervoy met the new co-primary PFS endpoint vs. chemotherapy in patients with high tumor mutation burden (TMB), regardless of PD-L1 status (see BioCentury, Feb. 16).

BMS disclosed in April that the PFS hazard ratio in patients with high TMB was 0.58 for Opdivo plus Yervoy compared with chemotherapy (97.5% CI: 0.41, 0.81, p=0.0002) (see BioCentury Extra, April 16).

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