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.”

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.