Get ready for the second wave of PD-1/L1 checkpoint inhibitors.
BeiGene $BGNE announced just ahead of the start of the week in Beijing that their PD-1 tislelizumab — partnered with Celgene $CELG — scored stellar data in a small Phase II trial for classical Hodgkin’s lymphoma among patients who had either failed or couldn’t take autologous stem cell transplantation. This is their first pivotal trial, and it underscores why Celgene inked a $1.4 billion deal to buy into the drug — which may end up as the 7th new checkpoint to hit the global market.
This is a very familiar arena for the checkpoint field. Bristol-Myers Squibb’s Opdivo gained an accelerated approval back in 2016 for cHL — with a 7% rate of CRs — and Merck was close behind with an OK a year ago as a 4th line therapy following promising results for Keytruda.
BeiGene, though, would be first in China, with a solid showing underscoring their drug’s potential.
In this new case their drug hit an objective response rate of 73%, with a 50% CR, and the median duration of response — over a 6-month average follow-up — had not been reached.
The transpacific BeiGene plans to hustle up an application in China while they work with Celgene on a late-stage program that includes trials for “non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma; as well as two global Phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T-and NK-cell lymphomas, and an additional pivotal Phase 2 trial in China in urothelial cancer.”
That’s not all.
BeiGene also announced that after discussions with the FDA they’re prepping an NDA for the first half of 2019 with plans to pursue an accelerated approval of their drug zanubrutinib for patients with Waldenström macroglobulinemia based on their global Phase I study. “A final determination to submit the NDA will be made subsequent to the pre-NDA meeting with FDA after obtaining mature data from the study this fall.”
Right now there are 5 PD-1/L1 checkpoints on the market. Regeneron $REGN and Sanofi $SNY plan to make that 6. And BeiGene looks well positioned to hit the 7th spot. As of now, there are still hundreds of ongoing trials, including a mob of combo studies, as Merck dukes it out with Bristol-Myers for the top position of a growing megamarket. As of now, Merck looks set to take the lead with a string of successes in frontline lung cancer.
Many of these new checkpoints are being studied in China, where a group of deep-pocket investors have been birthing new biopharma companies looking to fill the gap of drug tech that separates the booming Asian market with the West.
But there are also more than 150 of these experimental PD-1/L1 drugs in the global pipeline, according to research from the Cancer Research Institute, and eventually the world will either run out of uncharted oncology terrain, market potential or patients looking to enroll in a trial. Then the new arrivals will either shrivel or the whole market will be swiftly commoditized with multiple players.
That line, though, has not yet been reached.
“We are excited to announce the preliminary topline results from our first pivotal trial for tislelizumab. Despite short follow-up, we believe there was a demonstration of robust activity, with high overall and complete response rates in addition to a safety profile that is consistent with other PD-1 inhibitors. We believe these strong results will support our first regulatory filing in China for tislelizumab, which is planned for later this year,” commented Jane Huang, chief medical officer, hematology, at BeiGene.
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