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.”

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.