Mer­ck­'s Keytru­da takes home ad­ju­vant win in melanoma, es­ca­lat­ing ear­ly-line fight with Bris­tol My­ers

With im­mune check­point in­hibitors quick­ly emerg­ing as stan­dard of care across a broad range of ad­vanced can­cers, the biggest drug­mak­ers in the race are mak­ing a hard push in­to ear­li­er lines of ther­a­py to gain an edge. The biggest dog in the fight, Mer­ck, now has da­ta that could spell a quick ap­proval and sales bump.

Keytru­da beat out place­bo in staving off the re­cur­rence of can­cer as an ad­ju­vant ther­a­py in pa­tients with high-risk stage II melanoma af­ter surgery to re­move their tu­mors, ac­cord­ing to topline da­ta from the KEYNOTE-716 study re­leased Thurs­day.

Al­though full da­ta weren’t avail­able, the ear­ly look paints the pic­ture of a big win for Mer­ck, which is bat­tling for ear­li­er lines of ther­a­py for Keytru­da in a heat­ed fight among the PD-(L)1 play­ers, most no­tably Bris­tol My­ers Squibb’s Op­di­vo.

With da­ta in hand, Mer­ck snared a snap pri­or­i­ty re­view from the FDA with an ac­tion date set for Dec. 4. The drug­mak­er ex­pects to present full da­ta at an up­com­ing med­ical meet­ing.

The two-part KEYNOTE-716 study first ran­dom­ized pa­tients on Keytru­da or place­bo for up to a year of dos­ing af­ter surgery. That was fol­lowed by a two-year open-la­bel pe­ri­od for pa­tients who ei­ther did not see their dis­ease re­cur af­ter one year of Keytru­da or did see it re­cur on place­bo.

The da­ta add an­oth­er jew­el to Mer­ck’s crown in ad­ju­vant/neoad­ju­vant im­munother­a­py with oth­er wins in breast, blad­der and kid­ney can­cer al­ready on the mantle­piece.

Just days ago, the FDA ap­proved a reg­i­men of Keytru­da plus chemo as a neoad­ju­vant com­bo fol­lowed by ad­ju­vant Keytru­da monother­a­py in pa­tients with high-risk triple-neg­a­tive breast can­cer, which of­fi­cial­ly be­came the drug’s first win in that ear­ly-line set­ting.

The da­ta un­der­scor­ing that ap­proval were par­tic­u­lar­ly con­tentious: FDA hand­ed Mer­ck a com­plete re­sponse let­ter on the re­sults, cit­ing a lack of ma­ture safe­ty da­ta and ques­tions over the piv­otal study’s patho­log­ic com­plete re­sponse end­point. But Mer­ck with­in weeks rolled out that OS da­ta show­ing a win on more ma­ture sur­vival da­ta, and caus­ing the FDA to re­verse its ear­li­er de­ci­sion.

In ear­ly June, Mer­ck rolled out da­ta for Keytru­da in ad­ju­vant kid­ney can­cer, with the drug cut­ting the risk of can­cer re­lapse or death by 32% af­ter a lit­tle more than two years com­pared with place­bo in re­nal cell car­ci­no­ma pa­tients with a mid-to-high risk of re­cur­rence af­ter a kid­ney re­moval, or af­ter re­moval of a kid­ney and metasta­t­ic le­sions.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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