Mer­ck’s Keytru­da com­bo wows again, ac­ing PhI­II over­all sur­vival goal for lung can­cer ear­ly

Mer­ck’s Keytru­da team can chalk up an­oth­er big win in the race for PD-1/L1 dom­i­nance.

Their check­point in­hibitor added to chemo in a piv­otal study de­liv­ered “sig­nif­i­cant” ben­e­fits in over­all sur­vival as well as pro­gres­sion-free sur­vival among front­line non-small cell lung can­cer pa­tients — one of the big prizes in the ri­val­ry over a mega-block­buster mar­ket.

Roger Perl­mut­ter

They are de­clar­ing this suc­cess at an ear­ly, in­ter­im point —well ahead of ex­pec­ta­tions. The fi­nal OS read­out wasn’t ex­pect­ed un­til ear­ly next year. The new re­sults come just a few months af­ter Mer­ck rat­tled in­vestors with its de­ci­sion to yank a Eu­ro­pean ap­pli­ca­tion for Keytru­da for front­line use in the face of reg­u­la­to­ry re­sis­tance to the Phase II da­ta that were be­ing of­fered.

Mer­ck’s shares moved steadi­ly up­wards on the news, jump­ing 6% by mid-morn­ing with Roche stock skid­ding 3.7% and Bris­tol-My­ers shares down 2.7% as in­vestors placed their bets.

“The fact that MRK hit in KN-189 al­ready means Roche won’t get that leg up over MRK that was be­ing talked about post IMP-150 (al­so in 1L lung),” not­ed Ever­core ISI’s Uber Raf­fat.

Re­searchers at Mer­ck are stick­ing with the top-line re­sults for now, with hard num­bers on their KEYNOTE-189 study be­ing held for a sci­en­tif­ic con­fer­ence. But this is the first time that a check­point study has demon­strat­ed an over­all sur­vival ben­e­fit for this group.

Their will­ing­ness to in­clude OS to the study — which added Keytru­da to Eli Lil­ly’s Al­im­ta — un­der­scored Mer­ck’s con­fi­dence in their big can­cer drug, which has been mak­ing steady ad­vances since Bris­tol-My­ers Squibb stum­bled bad­ly last year with a clin­i­cal set­back that it has yet to re­cov­er from. There are now 5 of these PD-1/L1 drugs on the mar­ket, with a 6th on the way soon, and hun­dreds of com­bi­na­tion stud­ies like this have been mount­ed to find the best ap­proach, of­ten cen­ter­ing on chemo or in-house ther­a­pies like the CT­LA-4 drugs.

Leerink’s Sea­mus Fer­nan­dez says Mer­ck was able to keep its lead to­day, but the race isn’t over yet. His note:

We see these re­sults as fur­ther so­lid­i­fy­ing MRK’s cur­rent lead po­si­tion in the 1L NSCLC race; how­ev­er, full da­ta (to be pre­sent­ed at an up­com­ing meet­ing) will be nec­es­sary to com­pare with RHH­BY’s (NR) IM­pow­er150 tri­al of Tecen­triq (ate­zolizum­ab; an­ti-PD-L1) + Avastin (be­va­cizum­ab; an­ti-VEGF) + chemo, as well as up­com­ing read­outs from BMY’s (OP) Check­Mate-227 tri­al of Op­di­vo (nivolum­ab; an­ti-PD-1) + Yer­voy (ip­il­i­mum­ab; an­ti-CT­LA-4) and OS re­sults from AZN’s (MP) MYS­TIC tri­al of Imfinzi (dur­val­um­ab; an­ti-PD-L1) + treme­limuamb (an­ti-CT­LA-4).

“KEYNOTE-189 showed sig­nif­i­cant im­prove­ment in over­all sur­vival and pro­gres­sion-free sur­vival for pa­tients re­ceiv­ing Keytru­da in the first-line set­ting in com­bi­na­tion with tra­di­tion­al chemother­a­py, com­pared with those re­ceiv­ing chemother­a­py alone,” said Mer­ck R&D chief Roger Perl­mut­ter.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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UP­DAT­ED #ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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