Mer­ck $MRK has scored an­oth­er big win in its broad range of piv­otal Keytru­da stud­ies in lung can­cer.

This morn­ing in­ves­ti­ga­tors re­port that KEYNOTE-042 demon­strat­ed that pa­tients tak­ing their PD-1 check­point drug as a monother­a­py had a sig­nif­i­cant ad­van­tage over chemo alone in front­line non-small cell lung can­cer. The study of­fers an op­por­tu­ni­ty to treat lung can­cer with­out chemo, giv­ing pa­tients a route to for­go­ing some harsh side ef­fects.

Roger Perl­mut­ter

Sig­nif­i­cant­ly, the com­pa­ny test­ed over­all sur­vival in pa­tients ex­press­ing PD-L1 at 1% or high­er and swept the board. Eval­u­at­ing pa­tients with a tu­mor pro­por­tion score of ≥50 per­cent, with a TPS of ≥20 per­cent and then in the en­tire study pop­u­la­tion with a TPS of ≥1 per­cent, it hit on every mea­sure — win­ning out over Bris­tol-My­ers Squibb’s $BMY Op­di­vo, which failed in the over­all pop­u­la­tion as a so­lo ther­a­py.

The news gives Mer­ck an­oth­er leg up in the in­tense com­pe­ti­tion for lung can­cer pa­tients, where As­traZeneca $AZN has al­so been look­ing to carve out a ma­jor role for it­self with dur­val­um­ab.

In­vestors liked the sound of it all, dri­ving Mer­ck shares up 2.6% Mon­day morn­ing.

Amaz­ing how KEYNOTE-042 suc­ceed­ed in the en­tire > 1% co­hort that Bris­tol failed in years ago. Keytru­da is king.

— Brad Lon­car (@brad­lon­car) April 9, 2018

The phar­ma gi­ant didn’t of­fer any da­ta this morn­ing, wait­ing for an up­com­ing con­fer­ence. They’re al­so still eval­u­at­ing the pro­gres­sion-free sur­vival re­sults.

Mer­ck has fired up more than 700 clin­i­cal tri­als us­ing Keytru­da in var­i­ous set­tings, look­ing to over­take Bris­tol-My­ers as it eval­u­ates a new wave of stud­ies us­ing dif­fer­ent com­bi­na­tion ap­proach­es to can­cer.

“With KEYNOTE-042, Keytru­da has now shown a sig­nif­i­cant sur­vival ben­e­fit com­pared with chemother­a­py for pa­tients with lo­cal­ly ad­vanced or metasta­t­ic non­squa­mous or squa­mous NSCLC ex­press­ing PD-L1 at 1 per­cent or high­er by tu­mor pro­por­tion score,” said Roger Perl­mut­ter, the head of Mer­ck Re­search Lab­o­ra­to­ries. “Keytru­da is a foun­da­tion­al treat­ment for NSCLC and has con­sis­tent­ly demon­strat­ed a sur­vival ben­e­fit as monother­a­py, or in com­bi­na­tion with chemother­a­py, in the treat­ment of metasta­t­ic lung can­cer.”

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

When the FDA spurned Astellas’ pitch for atrial fibrillation drug vernakalant in 2008, regulators made it abundantly clear that it wasn’t the efficacy they had a problem with — two Phase III trials had shown the drug successfully restored 52% of patients’ heartbeat from irregular to normal — but the cardio safety issues for a drug that was to compete with well established, low-risk options. One licensing deal, one clinical hold and several studies later, the chances of approval aren’t looking any better.