New Delhi: Pfizer Inc. recently announced that the European Commission has approved VIZIMPRO (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
Commenting on the approval, Andreas Penk, M.D., regional president, Oncology International Developed Markets at Pfizer said, “Lung cancer remains the leading cause of cancer-related death worldwide and despite advances in biomarker-driven therapies, overcoming resistance continues to be crucial in treating EGFR-mutated non-small cell lung cancer.”
“The marketing authorization of VIZIMPRO, which has shown a more than five-month improvement in progression-free survival over an existing therapy in a Phase 3 clinical trial, provides a new option for patients with EGFR-mutated non-small cell lung cancer and reinforces Pfizer’s ongoing commitment to addressing the remaining needs of the thousands of EU patients with this disease,” Penk added.
The European Commission’s approval of VIZIMPRO was supported by data from ARCHER 1050, a randomized, multicenter, multinational, open-label, Phase 3 study conducted in patients with unresectable, metastatic or recurrent NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations.
A total of 452 patients were randomized 1:1 to VIZIMPRO 45 mg (n=227) or gefitinib 250 mg (n=225). The primary endpoint was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review. Key secondary endpoints included PFS assessed by the investigator, objective response rate (ORR), duration of response (DoR) and overall survival (OS).
A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to VIZIMPRO compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p
“Over the last two decades, biomarker-driven therapies have become standard-of-care for patients with EGFR-mutated non-small cell lung cancer,” said Dr Federico Cappuzzo, Director of Oncology and Hematology Department AUSL della Romagna-Ravenna.
“The improvement in progression-free survival for VIZIMPRO over a first-generation standard-of-care therapy in the ARCHER 1050 study is impressive, and I’m pleased it will be available for appropriate patients with non-small cell lung cancer in the EU,” Cappuzzo added.