A new player emerges in the non-small cell lung cancer (NSCLC) therapy scene

By Rajaneesh K Gopinath

Pfizer’s kinase inhibitor, Vizimpro bags USFDA approval for the treatment of a rare form of lung cancer which has a poor survival rate and is expected to hit the market from mid-October 2018.

The U.S. Food and Drug Administration approved Vizimpro (dacomitinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC), Pfizer announced on September 27^th in a news release (1). As per the detections made by an FDA approved test, the drug is approved for the treatment of patients harboring either of the two epidermal growth factor receptor (EGFR) mutations, the exon 19 deletion or exon 21 L858R substitution.

This approval was supported by a successful Phase III clinical trial, ARCHER 1050, a randomized, multicenter, multinational, open-label study in which dacomitinib was pitted against AstraZeneca’s lung cancer drug, Iressa (gefitinib). The trial was conducted jointly by Pfizer and SFJ Pharmaceuticals following their collaborative agreement in 2012. The detailed results of the trial were published last year in Lancet Oncology (2). A statistically significant improvement was demonstrated for dacomitinib in progression free survival (PFS) compared to gefitinib (hazard ratio 0.59 [95% CI: 0.47, 0.74], P<.0001). However, no significant improvements were observed in overall response rate (75% for dacomitinib vs 72% for gefitinib; P=0.39) or overall survival. The median PFS in the dacomitinib group was 14.7 months while the gefitinib arm recorded 9.2 months. The common adverse reactions following dacomitinib treatment include diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

Andy Schmeltz, global president of Pfizer Oncology said “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”. “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.”

Meanwhile, the FDA also approved the expanded use of Qiagen’s Therascreen®, an EGFR RGQ PCR Kit as a companion diagnostic for Vizimpro (3). Therascreen® was earlier used together with gefitinib and Boehringer Ingelheim’s GILOTRIF® (Afatinib).

References

1. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_vizimpro_dacomitinib_for_the_first_line_treatment_of_patients_
   with_egfr_mutated_metastatic_non_small_cell_lung_cancer
2. https://www.ncbi.nlm.nih.gov/pubmed/28958502
3. https://corporate.qiagen.com/newsroom/press-releases/2018/20180928_fda_egfr

Author

Rajaneesh K. Gopinath