Roche/Genentech CMO Levi Garraway

ASH: Roche's an­ti­body-drug con­ju­gate Po­livy added to chemo-an­ti­body com­bo boosts sur­vival in ear­ly-stage lym­phoma

Break­throughs in drug de­vel­op­ment have be­gun to un­lock the po­ten­tial of an­ti­body-drug con­ju­gates, ther­a­pies de­signed to bet­ter tar­get pro­teins on tu­mor cells. Genen­tech’s Po­livy has be­come an ear­ly win­ner in blood can­cer, and now the drug­mak­er is re­veal­ing promis­ing re­sults in get­ting in­to pa­tients even soon­er.

A com­bi­na­tion of Roche’s Po­livy, an ADC tar­get­ing the CD79b pro­tein on tu­mor cells, with Rit­ux­an and the chemother­a­py reg­i­men R-CHOP cut the risk of dis­ease pro­gres­sion or death over Rit­ux­an-chemo alone by 27% in pa­tients with first-line dif­fuse large B cell lym­phoma, ac­cord­ing to late-break­ing da­ta pre­sent­ed Tues­day at #ASH21.

In the 879-en­rollee Phase III PO­LAR­IX study, pa­tients dosed with the Po­livy com­bo showed sig­nif­i­cant im­prove­ment on me­di­an pro­gres­sion-free sur­vival at a 28.2-month check-in, Genen­tech said.

Mean­while, the ADC-based com­bo post­ed a Grade 3-4 side ef­fect rate of 57.7% com­pared with 57.5% for the SOC chemo com­bo. Three per­cent of pa­tients died in the treat­ment arm com­pared with 2.4% in con­trol, and 9.2% of pa­tients in the Po­livy arm dis­con­tin­ued due to dos­ing com­pared with 13% in the Rit­ux­an-chemo arm.

These full da­ta back up topline re­sults that were re­leased back in Au­gust, with Roche tout­ing Po­livy’s chances at sig­nif­i­cant­ly ex­tend­ing pa­tients’ lives for a dis­ease in which four of 10 pa­tients even­tu­al­ly re­lapse af­ter treat­ment with SOC in the first-line set­ting. The drug works by tar­get­ing CD79b on the sur­face of B cells and de­liv­er­ing an an­ti-can­cer agent to the site.

Po­livy was de­vel­oped from ADC tech­nol­o­gy at Seagen. Roche has al­ready sub­mit­ted what it had on hand with glob­al health reg­u­la­tors, with these re­sults back­ing up those fil­ings.

The cur­rent gen­er­a­tion of AD­Cs has shown some sig­nif­i­cant break­throughs in the treat­ment of sol­id tu­mors, in­clud­ing drugs like As­traZeneca and Dai­ichi Sankyo’s En­her­tu, which tar­gets the HER2 pro­tein on tu­mors. Mean­while, in blood can­cer, a new gen­er­a­tion of AD­Cs has re­cent­ly bro­ken through, in­clud­ing Po­livy, which was ini­tial­ly ap­proved in 2019 in com­bi­na­tion with Rit­ux­an as a treat­ment for re­lapsed or re­frac­to­ry DL­B­CL.

These newest da­ta al­so add more va­lid­i­ty to tar­get­ing CD79b as part of a range of can­cer com­bi­na­tions, po­ten­tial­ly of­fer­ing physi­cians more paths to killing tu­mors. In lym­phoma, CD19 and CD20 have ce­ment­ed them­selves as the most pro­lif­ic tar­gets among can­cer drugs, but Roche has looked to part­ner up Po­livy along­side Rit­ux­an, it­self a CD20 mon­o­clon­al an­ti­body, among oth­er team-ups.

Those com­bo stud­ies in­clude com­bin­ing Po­livy with Genen­tech’s in-house bis­pe­cif­ic an­ti­bod­ies mo­sune­tuzum­ab and glofi­ta­m­ab, both of which tar­get CD20. The drug­mak­er is al­so look­ing at Po­livy com­bos with the BCL-2 in­hibitor vene­to­clax, and with Rit­ux­an in com­bi­na­tion with chemother­a­pies gem­c­itabine and ox­ali­platin in the Phase III PO­LARGO study.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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