Pfizer/Merck KGaA’s pivotal Phase III Bavencio/Inlyta first-line RCC trial meets initial 500+ enrollment target in summer 2017; future accrual in 830 expansion a challenge – source

26 Sep 2017

Pfizer/Merck KGaA’s pivotal Phase III Bavencio/Inlyta first-line RCC trial meets initial 500+ enrollment target in summer 2017; future accrual in 830 expansion a challenge – source

Pfizer (NYSE:PFE) and Merck KGaA’s (ETR:MRK) Phase III first-line advanced renal cell carcinoma (RCC) JAVELIN 101 study of PD-L1 inhibitor Bavencio (avelumab) in combination with Pfizer’s Inlyta (axitinib) met its initial recruitment target of 583 patients in summer 2017, said a source familiar with the trial. Shortly after reaching the target, the source noted, the company amended its study to increase the patient population, and data released at the recent ESMO Congress will likely place additional recruitment pressure on the trial due to its control arm choice of Pfizer's Sutent (sunitinib), he added. Two other oncologists agreed on potential recruitment hurdles for first-line RCC trials moving forward.

Pfizer has made no public announcement about the trial’s (NCT02684006) recruitment status or amendments. The study started in March 2016 and was amended on 25 July, increasing its target to 830, and its June 2018 primary completion was changed to December 2018 on 20 September, according to ClinicalTrials.gov.

Bavencio’s total revenues across all cancer indications in 2023 are estimated to be USD 1.37bn, according to BioPharm Insight data.

The reason for the trial size amendment was possibly to make the trial comparable with other Phase III first-line studies, the source noted. Future accrual for this study along with other first-line RCC studies that are using Pfizer’s Sutent as a treatment in the control arm may be challenging due to the recent updated positive data of Bristol-Myers Squibb’s (NYSE:BMY) Opdivo (nivolumab) and Yervoy (ipilimumab) in the same setting, the source added.

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