When Eli Lil­ly inked a $1 bil­lion-plus deal to grab ex-Chi­na com­mer­cial­iza­tion rights for In­novent’s PD-1 Tyvyt (sin­til­imab), the part­ners hailed the “clin­i­cal pro­file” of the drug they co-de­vel­oped and vowed to keep ex­plor­ing its po­ten­tial across tu­mor types.

One year lat­er, Tyvyt has notched an­oth­er big win on its home turf.

Suzhou-based In­novent says at the in­ter­im analy­sis, the drug hit the pri­ma­ry end­point of over­all sur­vival in ORI­ENT-16, a Phase III clin­i­cal tri­al for un­re­sectable, lo­cal­ly ad­vanced, re­cur­rent or metasta­t­ic gas­tric or gas­troe­sophageal junc­tion (GEJ) ade­no­car­ci­no­ma. Specif­i­cal­ly, it pits a com­bi­na­tion of the PD-1 in­hibitor and chemother­a­py (ox­ali­platin and capecitabine) against chemo alone.

The ex­act OS num­bers are be­ing held back for a med­ical meet­ing, al­though In­novent sug­gests that the re­sults will sup­port a sup­ple­men­tal NDA with the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

“ORI­ENT-16 is the first Phase 3 clin­i­cal tri­al in Chi­na to demon­strate an an­ti-PD-1 an­ti­body in com­bi­na­tion with chemother­a­py sig­nif­i­cant­ly pro­longed over­all sur­vival in the first-line treat­ment of ad­vanced gas­tric can­cer,” said Jian­ming Xu, the tri­al’s prin­ci­pal in­ves­ti­ga­tor and a pro­fes­sor at the Fifth Med­ical Cen­ter of Peo­ple’s Lib­er­a­tion Army Gen­er­al Hos­pi­tal.

He not­ed that near­ly half of all gas­tric can­cer cas­es — al­ready one of the most com­mon tu­mor types glob­al­ly — are di­ag­nosed in Chi­na.

In the US, Bris­tol My­ers Squibb has tout­ed pos­i­tive re­sults with Op­di­vo in the same set­ting, while Mer­ck’s Keytru­da is ap­proved to­geth­er with Her­ceptin and chemo specif­i­cal­ly for HER2-pos­i­tive gas­tric or GEJ ade­no­car­ci­no­ma.

With the new tri­al, Tyvyt has now shown ef­fect as a front­line ther­a­py for five ma­jor types of can­cer, added Zhou Hui, In­novent’s SVP of clin­i­cal de­vel­op­ment: non­squa­mous non-small cell lung can­cer, squa­mous non-small cell lung can­cer, he­pa­to­cel­lu­lar car­ci­no­ma, esophageal squa­mous cell car­ci­no­ma, as well as gas­tric can­cer.

To­geth­er with Lil­ly, which paid $200 mil­lion up­front to com­mer­cial­ize the drug in the US and oth­er mar­kets, it has re­cent­ly filed for its first FDA ap­proval in non­squa­mous NSCLC.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.