Michael Yu, Innovent CEO (Anthony Kwan/Bloomberg via Getty Images)

As US re­view of Eli Lil­ly-part­nered PD-1 gets un­der­way, In­novent touts an­oth­er front­line win in Chi­na

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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

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.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

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.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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