BeiGene’s en­try to the PD-1 mar­ket — as the fourth do­mes­tic drug­mak­er to score ap­proval in Chi­na, lag­ging months be­hind multi­na­tion­al play­ers — might have been un­re­mark­able. But the fol­low-up act is where it plans to shine.

Three months af­ter post­ing pos­i­tive top-line pro­gres­sion-free sur­vival re­sults for their piv­otal Chi­nese study with tislelizum­ab and chemo for front­line squa­mous non-small cell lung can­cer, BeiGene said the PD-1 an­ti­body hit the same mark for non-squa­mous cas­es of NSCLC. In both tri­als, the drug was paired with chemother­a­py and the reg­i­men was com­pared to chemo alone.

Why does it mat­ter? SVB Leerink an­a­lyst An­drew Berens summed it up this way:

This pos­i­tive out­come in non-squa­mous NSCLC, and pri­or suc­cess in squa­mous NSCLC, along with ap­proved in­di­ca­tions in blad­der can­cer and clas­sic Hodgkin’s lym­phoma, could po­ten­tial­ly en­able Tisle to have the broad­est la­bel among all Chi­na do­mes­tic PD-1/L1 agents, which could give the com­pa­ny a com­pet­i­tive ad­van­tage and broad na­tion­al re­im­burse­ment, which could ul­ti­mate­ly chal­lenge the multi­na­tion­al agents.

The com­pa­ny has in­di­cat­ed that it plans to sub­mit an sN­DA for first-line squa­mous NSCLC in Chi­na in 2020. Once the over­all sur­vival re­sults, which con­sti­tute one of the sec­ondary end­points in these tri­als, are in, Berens ex­pects BeiGene to lever­age the datasets to sup­port po­ten­tial fil­ing in the US.

Yong Ben

Tislelizum­ab is be­ing stud­ied in more than 25 tri­als world­wide, added Yong Ben, CMO of im­muno-on­col­o­gy. They in­clude a Phase III pit­ting the drug against do­c­etax­el in sec­ond-line or third-line NSCLC, ex­pect­ed by ear­ly 2021, in ad­di­tion to tri­als in he­pa­to­cel­lu­lar car­ci­no­ma and esophageal can­cer.

Berens es­ti­mates peak rev­enues at $460 mil­lion in Chi­na, with $28 mil­lion in 2020 — which he said “could prove to be very con­ser­v­a­tive if the com­pa­ny is able to cap­ture a sig­nif­i­cant por­tion of the rapid­ly grow­ing PD-1 mar­ket.”

CEO John Oyler is go­ing all out. Just days ago BeiGene nabbed its first sol­id tu­mor OK in lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma. Chi­na’s Na­tion­al Med­ical Prod­uct Ad­min­is­tra­tion, which grant­ed the sN­DA pri­or­i­ty re­view pre-pan­dem­ic, based its de­ci­sion on a sin­gle-arm piv­otal Phase II.

It marked tislelizum­ab’s sec­ond in­di­ca­tion af­ter the ini­tial ap­proval for clas­si­cal Hodgkin’s lym­phoma in De­cem­ber 2019.

Like urothe­lial can­cer, pa­tients with Stage II­IB or Stage IV non-squa­mous NSCLC are al­so in need of more treat­ment op­tions, BeiGene said. Its ri­vals at In­novent and Hen­grui ev­i­dent­ly agree, lin­ing up their own pro­grams to tack­le the mar­ket.

Troy Wilson was working with J&J on their KRAS inhibitor and periodically thumbing through their publications when he spotted an old drug called tipifarnib that looked promising. So promising, in fact, that the large pharma had run it through over 5,000 patients across 70 trials, hoping they would at some point be able to nail down who were the small slice of patients who responded in some studies.

We now know the full, early-stage story behind the drug that inspired Gilead CEO Dan O’Day’s recent $5 billion acquisition of Forty Seven.

Following up on their ASCO abstract from a couple of weeks ago, the team at Forty Seven is making their return appearance this week holding clearly promising early-stage data on their lead drug magrolimab as they ponder whether they should roll on a quest to obtain an accelerated approval.

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.