Roche scores its first PD-L1 win in China, going straight for SCLC niche
Just weeks after AstraZeneca’s Imfinzi became the first and only approved PD-L1 drug in China, regulators have ushered in Roche’s Tecentriq to the checkpoint frenzy.
The Swiss pharma giant is going straight for a niche that it knows well: extensive-stage small cell lung cancer. Per its estimates, two thirds of SCLC patients have reached this phase by the time they are diagnosed, leading to a poor prognosis and an average 5-year survival rate of 2% despite the use of chemo.
As with the US OK, China’s National Medical Products Association based its approval on the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival 12.3 months vs 10.3 months; p=0.0069). The Tecentriq combo also reduced the risk of the disease worsening, with progression-free survival reaching 5.2 months compared to 4.3 months on chemo alone (p=0.017).
Thanks to reforms instituted in 2017, these data collected from global studies went on to support China approval.
“In March 2019, the US FDA approved Tecentriq for the small cell lung cancer indication,” Hong Zhou, Roche’s China general manager, said in a statement posted on WeChat. “In less than a year’s time, Tecentriq was approved in China for small cell lung cancer. It is another testament to the resolution as well as results of the Chinese government speeding up the review of new drugs such that Chinese patients can have access to the latest drugs as Europeans and Americans.”
With PD-1 leaders Merck and Bristol-Myers already in the market, Roche indicated that it would continue to pursue the niche finding strategy that has suit it well, focusing on smaller patient population other immunotherapies may not have reached.
The win for Tecentriq in small cell lung cancer, it added, means it has full coverage of the lung cancer landscape in China. Tarceva (anti-EGFR), Alecensa (anti-ALK) and Avastin (anti-VEGF) are all positioned for non-small cell lung cancer.