Re­gen­eron and Sanofi pull Lib­tayo app in cer­vi­cal can­cer, cit­ing post-mar­ket study dis­agree­ment with FDA

Sanofi and Re­gen­eron on Fri­day said they’ve de­cid­ed to pull their sBLA for their PD-1 Lib­tayo (cemi­plimab-rwlc) in sec­ond-line cer­vi­cal can­cer af­ter the com­pa­nies and the FDA were not able to align on cer­tain post-mar­ket­ing stud­ies that pre­sum­ably would’ve been re­quired had it won ap­proval.

Nei­ther Sanofi nor Re­gen­eron was will­ing to elab­o­rate on this dis­con­nect over the post-mar­ket­ing re­quire­ments, but talks with reg­u­la­tors out­side the US re­main on­go­ing.

“We’re notic­ing a pat­tern with FDA on non-align­ment on post-mar­ket­ing stud­ies, which cre­ates un­cer­tain­ty for drug­mak­ers,” in­vest­ment an­a­lysts at Tru­ist Se­cu­ri­ties said in a note on the an­nounce­ment Fri­day. “FDA is not mak­ing the path for­ward eas­i­er. It could be be­cause there are oth­er drugs com­ing down the pipeline that are po­ten­tial­ly bet­ter and safer, which rais­es the bar.”

Tru­ist al­so not­ed that oth­er com­pa­nies may find chal­lenges in pur­su­ing evolv­ing and com­pet­i­tive ther­a­peu­tic land­scapes such as this one, par­tic­u­lar­ly as “it be­comes more dif­fi­cult to re­cruit for these con­fir­ma­to­ry and post-mar­ket­ing stud­ies in a rea­son­able time,” which com­pa­nies “may think it’s not worth the in­vest­ment.”

Ear­li­er this week, In­cyte said it made the “busi­ness de­ci­sion” to with­draw an NDA for parsaclis­ib, its oral PI3Kδ in­hibitor, af­ter de­cid­ing that run­ning the con­fir­ma­to­ry stud­ies the agency was ask­ing for to sup­port an ac­cel­er­at­ed ap­proval wouldn’t be worth it.

Fri­day’s news for Sanofi and Re­gen­eron came as a sur­prise as the com­pa­nies pre­vi­ous­ly halt­ed a Phase III cer­vi­cal can­cer tri­al ear­ly af­ter Lib­tayo was shown to cut the risk of death by 31% over chemother­a­py, paving the way for this pri­or­i­ty re­view sub­mis­sion (the PDU­FA date was Jan. 30).

A Re­gen­eron spokesper­son con­firmed that the com­pa­ny was not amend­ing its state­ment from March re­gard­ing the tri­al re­sults.

The tri­al win in March fol­lowed a string of two quick ap­provals that came with­in weeks of each oth­er, vast­ly ex­pand­ing Lib­tayo’s la­bel and, for the first time, pit­ting it against Mer­ck’s dom­i­nant PD-1 star Keytru­da.

In­vent­ed with Re­gen­eron’s pro­pri­etary Ve­locIm­mune tech, Lib­tayo has shown sig­nif­i­cant sales growth in re­cent years, as it’s ap­proved for cer­tain pa­tients with ad­vanced basal cell car­ci­no­ma, ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma (CSCC), and ad­vanced non-small cell lung can­cer.

Re­gen­eron, which records net prod­uct sales of Lib­tayo in the US, re­port­ed about $340 mil­lion in Lib­tayo sales in the first nine months of 2021, a 34% in­crease over 2020.

And Sanofi, which records net prod­uct sales of Lib­tayo out­side the US, said sales amount­ed to €59 mil­lion ($66 mil­lion) in the first half of 2021, dri­ven by in­creased de­mand in the treat­ment of metasta­t­ic CSCC and by the launch of the prod­uct for that in­di­ca­tion in new coun­tries.

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

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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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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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

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

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

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.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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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.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.