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.”

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”