Pfizer (PFE) Presents Encouraging New Data for INLYTA Combo Phase 1b in Adv. RCC

October 10, 2016 6:35 AM EDT

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Pfizer Inc. (NYSE: PFE) today announced data from an ongoing, investigational Phase 1b study of INLYTA® (axitinib) combined with the checkpoint inhibitor pembrolizumab (A4061079, NCT02133742), a PD-1 inhibitor known as KEYTRUDA® and marketed by Merck, known as MSD outside the United States and Canada, in treatment-naïve patients with advanced renal cell carcinoma (RCC). The study was designed to establish dosing and evaluate the safety and anti-tumor activity of INLYTA when combined with pembrolizumab in first-line treatment of advanced RCC.

Preliminary results from a similar, separate study combining INLYTA with avelumab (JAVELIN Renal 100, NCT02493751), an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody that is being co-developed by Merck KGaA, Darmstadt, Germany, and Pfizer were also presented. The data suggest evidence of anti-tumor activity for INLYTA in combination with avelumab and were presented during a poster discussion session at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology being held in Copenhagen, Denmark.

Based on these Phase 1 results, two independent global Phase 3 trials evaluating these combinations - INLYTA plus pembrolizumab and INLYTA plus avelumab – each compared with SUTENT® (sunitinib) in first-line advanced RCC are now enrolling patients.

“Combining immunotherapy agents with currently approved therapies such as INLYTA may provide a meaningful improvement in outcome for patients with renal cancer,” said Chris Boshoff, M.D., Ph.D., head of immuno-oncology, early development and translational oncology, Pfizer Global Product Development. “The results presented today indicate that there is a potential additive or synergistic effect between INLYTA and a checkpoint inhibitor in RCC.”

Early indicators from the A4061079 study point to strong response rates with the INLYTA/pembrolizumab combination, with 37 patients (71.2%, confidence internal 56.9, 82.9) achieving objective responses (three complete responses and 34 partial responses); 10 patients had stable disease and 5 patients had disease progression.

Separately, in the JAVELIN Renal 100 study of INLYTA in combination with avelumab, five out of six patients treated so far had confirmed partial responses (objective response rate 83.3%, 95% confidence interval: 35.9, 99.6) and one patient with tumor shrinkage not meeting partial response criteria had stable disease.

INLYTA is an oral vascular endothelial growth factor (VEGF) receptor inhibitor for the treatment of patients with advanced RCC after failure of one prior systemic therapy approved in 63 countries. It was the first treatment to demonstrate superior progression-free survival benefit in a Phase 3 study versus sorafenib, a tyrosine kinase inhibitor, in second-line treatment of advanced RCC.

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