The FDA approved dacomitinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletion or exon 21 L858R substitution mutations.
Dacomitinib (Vizimpro, Pfizer) is a once-daily oral pan-human EGFR tyrosine kinase inhibitor.
The FDA based this approval on results from the multicenter, multinational open-label phase 3 ARCHER 1050 trial.
“EGFR-mutated advanced NSCLC is a common illness, especially in the Asian population, and new treatment options will ultimately benefit patients,” Tony Mok, MD, chair of the department of clinical oncology at The Chinese University of Hong Kong, said in a company-issued press release. “The findings from ARCHER 1050 suggest that Vizimpro should be considered as a new first-line treatment option for patients with EGFR-mutated NSCLC exon 19 deletion or exon 21 L858R substitution mutations.”
The analysis included 425 patients with unresectable metastatic NSCLC who had no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease free after completing systemic therapy. All patients had EGFR exon 19 deletion or exon 21 L858R substitution mutations and an ECOG performance status of 0 or 1.
Researchers assigned half of patients to dacomitinib. The remaining patients received gefitinib (Iressa, AstraZeneca).
As HemOnc Today previously reported, researchers presented results from the ARCHER 1050 trial at this year’s ASCO Annual Meeting.
PFS as determined by independent review served as the primary endpoint.
Results showed a statistically significant improvement in median PFS among patients treated with dacomitinib compared with those treated with gefitinib (14.7 months vs. 9.2 months; HR = 0.59; 95% CI, 0.47-0.74).
“Improving outcomes for patients is the central focus of why we develop and deliver new medicines. Vizimpro is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need,” Andy Schmeltz, global president at Pfizer Oncology, said in the release. “With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach.”
Among patients treated with dacomitinib, the most common adverse reactions included diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%) and pruritus (21%).
Serious adverse reactions occurred among 27% of patients treated with dacomitinib. The most common serious adverse reactions reported were diarrhea (2.2%) and interstitial lung disease (1.3%).
The FDA granted the dacomitinib application priority review in April.
The FDA also approved the expanded use of the Therascreen EGFR RGQ PCR Kit (Qiagen) for use as a companion diagnostic for dacomitinib for the first-line indication.
The Therascreen assay detects exon 19 deletions; L858R, L861Q, G719X, S768I and exon 20 insertions; and the T790M resistance mutation in the EGFR gene. The assay already is approved for use as a companion diagnostic for afatinib (Gilotrif, Boehringer Ingelheim) and gefitinib (Iressa, AstraZeneca).