As­traZeneca earns an­oth­er ap­proval in jam-packed Chi­nese PD-(L)1 mar­ket, this time in late-stage lung can­cer

One of the first en­trants in the PD-(L)1 mar­ket in Chi­na, British drug­mak­er As­traZeneca is now look­ing to ce­ment its ad­van­tage there with an­oth­er ap­proval for check­point in­hibitor Imfinzi.

Imfinzi was ap­proved by Chi­na’s NM­PA as a com­bi­na­tion with plat­inum-based chemother­a­py for first-line use in “ex­ten­sive-stage” small cell lung can­cer, an ad­vanced form of the dis­ease as­so­ci­at­ed with par­tic­u­lar­ly poor out­comes for pa­tients, the drug­mak­er said Mon­day.

The agency based its re­view on da­ta from the Phase III CASPI­AN study, which found Imfinzi plus chemo cut the risk of death by 27% rel­a­tive to chemo alone, As­traZeneca said. Those topline re­sults re­leased in June 2019 showed a me­di­an over­all sur­vival of 13 months com­pared with 10.3 for the chemo so­lo arm. An es­ti­mat­ed 22.2% of pa­tients treat­ed with Imfinzi plus chemo were alive at a two-year fol­low-up com­pared with 14.4% for chemo alone, As­traZeneca said.

Most im­por­tant­ly for Chi­nese reg­u­la­tors, those over­all re­sults were con­sis­tent for the Chi­nese co­hort of pa­tients.

Back in March 2020, the FDA hand­ed down its own ap­proval in the same pa­tients, set­ting the stage for a glob­al roll­out based on the CASPI­AN find­ings.

As­traZeneca’s Imfinzi first en­tered the in­creas­ing­ly com­pet­i­tive Chi­nese PD-(L)1 mar­ket back in De­cem­ber 2019, earn­ing an ap­proval in un­re­sectable non-small cell lung can­cer and be­com­ing the first drug of its kind ap­proved to treat Chi­nese pa­tients. Since then, the field has sky­rock­et­ed as oth­er glob­al drug­mak­ers and now home­grown Chi­nese play­ers have looked to cap­i­tal­ize on the boom.

In the US, there are sev­en ap­proved PD-(L)1s, with Mer­ck’s Keytru­da lead­ing the way in terms of sales. But in Chi­na, there are as many as 10 of those drugs on the mar­ket, with an in­creas­ing num­ber com­ing from na­tive bio­phar­mas work­ing with glob­al part­ners.

As­traZeneca, for in­stance, al­so has a com­mer­cial­iza­tion deal with ma­jor play­er Jun­shi Bio­sciences on PD-1 drug tori­pal­imab, which was first ap­proved for Chi­nese use in sec­ond-line melanoma back in De­cem­ber 2018. As part of that un­usu­al deal, As­traZeneca holds rights to mar­ket the drug in urothe­lial can­cer across Chi­na with an op­tion to pur­sue oth­er emerg­ing mar­kets. Jun­shi, mean­while, al­so holds an ex-Chi­na com­mer­cial­iza­tion deal with Co­herus as well for tori­pal­imab, with the col­lab­o­ra­tion pur­su­ing a fil­ing with the FDA.

As Chi­nese on­col­o­gy R&D grows broad­er, more and more West­ern phar­mas have piled in as col­lab­o­ra­tors — con­sid­er deals like No­var­tis’ pact with BeiGene on tislelizum­ab — while those grow­ing Chi­nese play­ers have looked to crack a US mar­ket with less com­pe­ti­tion and high­er bar­ri­ers to en­try. Drug­mak­ers like Jun­shi, Hutchmed and CStone all have can­di­dates filed for ap­proval in the US, po­ten­tial­ly of­fer­ing a path­way to the sort of price com­pe­ti­tion that so far hasn’t been a fac­tor in that mar­ket.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

How the bio­phar­ma in­dus­try is help­ing to pay for the bi­par­ti­san in­fra­struc­ture bill

Senators on Sunday finalized the text of a massive, bipartisan infrastructure bill that contains little that might impact the biopharma industry other than two ways the legislators are planning to pay for the $1.2 trillion deal.

On the one hand, senators are seeking to further delay a Trump-era Medicare Part D rule related to drug rebates, this time until 2026. Senators claim the rule could end up saving about $49 billion, but the PBM industry has attacked it as it would remove rebates from a safe harbor that provides protection from federal anti-kickback laws. The pharmaceutical industry, however, is in favor of the rule and opposes this latest delay as it continues to point its finger at the PBM industry for the rising cost of out-of-pocket expenses.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.