Bris­tol My­ers adds to neoad­ju­vant win for Op­di­vo in lung can­cer, es­ca­lat­ing ear­ly can­cer show­down with Mer­ck

Bris­tol My­ers Squibb and Mer­ck are locked in a heat­ed race to bring their block­buster PD-(L)1 drugs in­to ear­ly can­cer pa­tients as part of po­ten­tial­ly cu­ra­tive com­bi­na­tions. The ap­provals have been com­ing fast and heavy, and Bris­tol My­ers keeps adding to its case for a big-time FDA nod in lung can­cer.

A com­bi­na­tion of Op­di­vo and chemo in the neoad­ju­vant set­ting be­fore surgery cut the risk of re­cur­rence or death in pa­tients with stage IB to II­IA non-small cell lung can­cer over pre-surgery chemo alone, ac­ing the sec­ond pri­ma­ry end­point in the Phase III CHECK­MATE-816 study, Bris­tol My­ers said Mon­day.

There were no hard da­ta in Mon­day’s re­lease, but the drug­mak­er said an in­ter­im analy­sis came up aces for the Op­di­vo com­bo, which Bris­tol My­ers an­nounced back in April hit the oth­er pri­ma­ry end­point in this study: an im­prove­ment in patho­log­i­cal com­plete re­sponse.

Bris­tol My­ers and Mer­ck with megablock­buster Keytru­da are lead­ing the pack in terms of bring­ing check­point in­hibitors in­to ear­ly can­cer pa­tients be­fore their dis­ease ever ad­vances in­to the metasta­t­ic stage. In NSCLC, Bris­tol My­ers fore­casts a big mar­ket for its drug, and it’s not hard to see why: The drug­mak­er es­ti­mates that be­tween 30% and 55% of NSCLC pa­tients re­lapse af­ter surgery, un­der­scor­ing the need for ad­di­tion­al ther­a­pies to knock down that risk.

Bris­tol My­ers said it plans to present full da­ta at an up­com­ing med­ical meet­ing as well as with reg­u­la­tors.

Back in April, the drug­mak­er rolled out da­ta for the Op­di­vo-chemo com­bo show­ing it post­ed a 24% patho­log­i­cal com­plete re­sponse (pCR) rate for pa­tients across the PD-(L)1 ex­pres­sion spec­trum  com­pared with just 2.2% for chemo alone. That pCR end­point is a con­tro­ver­sial one and has led to some back­lash — in­clud­ing at a heat­ed ad­comm for a Keytru­da reg­i­men in triple-neg­a­tive breast can­cer — but adding a pos­i­tive EFS read­out could go a long way to sooth­ing reg­u­la­tors’ con­cerns.

Even with Mer­ck neck-and-neck across a grow­ing range of tu­mor types in the neo/ad­ju­vant set­ting, Bris­tol My­ers thinks it has a lead­er­ship po­si­tion here and is build­ing its own case for Op­di­vo, ei­ther alone or in com­bi­na­tion with chemo, as the go-to PD-(L)1 for ear­ly can­cer pa­tients.

The drug­mak­er now sports FDA ap­provals in ad­ju­vant urothe­lial can­cer, ad­ju­vant esophageal or gas­troe­sophageal junc­tion (GEJ) can­cer and ad­ju­vant melanoma.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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