As­traZeneca caps its big win in lung can­cer with pos­i­tive sur­vival da­ta for Imfinzi — and what a re­lief it is

As­traZeneca capped its big win on the land­mark PA­CIF­IC study to­day with the news that its PD-L1 check­point Imfinzi de­liv­ered a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival for a key seg­ment of the lung can­cer mar­ket. 

Pas­cal So­ri­ot

The OS score dur­ing an in­ter­im analy­sis is for pa­tients whose stage III non-small cell lung can­cer hasn’t pro­gressed af­ter chemora­di­a­tion and whose tu­mors can’t be sur­gi­cal­ly re­moved. The da­ta here — specifics will fol­low at a con­fer­ence — will help As­traZeneca con­sol­i­date a cru­cial lead spot for it­self, which As­traZeneca CEO Pas­cal So­ri­ot has boast­ed will put the phar­ma gi­ant in the lead for “half the pool in lung can­cer.”

The FDA has al­ready come through with an OK for As­traZeneca here, un­der­scor­ing that reg­u­la­tors aren’t wait­ing for every i to be dot­ted and every t crossed be­fore get­ting new can­cer drugs to pa­tients and doc­tors.

Dave Fredrick­son

The im­por­tance of the very re­al suc­cess here for So­ri­ot is hard to over­state. The CEO has to cap­i­tal­ize on ad­vances for the can­cer drug port­fo­lio to prove to in­vestors that new drugs can fi­nal­ly pro­vide the fi­nan­cial turn­around that As­traZeneca has to have as the Crestor fran­chise melts away. PA­CIF­IC is blaz­ing a path for a would-be block­buster that can let So­ri­ot prove that.

Just a few days ago Dave Fredrick­son, who heads up the on­col­o­gy busi­ness unit for As­traZeneca, told an­a­lysts that PA­CIF­IC had swift­ly opened up a valu­able mar­ket seg­ment demon­strat­ing some pow­er­ful po­ten­tial. He not­ed:

This has re­sult­ed in a true in­flec­tion point for Imfinzi with sales now at $62 mil­lion in the first quar­ter and re­al­ly the over­whelm­ing ma­jor­i­ty of these com­ing from the lung can­cer in­di­ca­tion. As you saw from a slide that Pas­cal showed in Feb­ru­ary when we launched, we had about 3,500 pa­tient in­fu­sions per month and you could see that we’ve now dou­bled in the most re­cent month to 7,000 pa­tient in­fu­sions per month, re­al­ly show­ing that the un­der­ly­ing pa­tient de­mand is the dri­ver of these sales. 

Sean Bo­hen

The suc­cess in this seg­ment gives As­traZeneca’s can­cer team added cred­i­bil­i­ty for un­der­stand­ing how to score a strate­gic ad­vance in an in­tense­ly com­pet­i­tive field, with Mer­ck and Bris­tol-My­ers tus­sling for dom­i­nance in front­line lung can­cer. Com­ing on the heels of the em­bar­rass­ing first-round MYS­TIC fail­ure, it al­so of­fered an en­cour­ag­ing en­dorse­ment for the com­pa­ny’s R&D com­pe­tence.

As­traZeneca CMO Sean Bo­hen said: “The read­out of pos­i­tive over­all sur­vival da­ta at the in­ter­im analy­sis of the PA­CIF­IC tri­al pro­vides ad­di­tion­al com­pelling ev­i­dence of the clin­i­cal ben­e­fit that Imfinzi can of­fer pa­tients in this ear­li­er stage of lung can­cer.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.