FDA ush­ers Mer­ck­'s star can­cer drug Keytru­da to­ward an­oth­er key check­point

Mer­ck counts 22 ap­proved in­di­ca­tions for Keytru­da across 14 dif­fer­ent can­cer types. It is now be­ing ush­ered to­ward one more.

The PD-1 block­buster has been grant­ed pri­or­i­ty re­view for an­oth­er set of blad­der can­cer pa­tients: those with high-risk non-mus­cle in­va­sive blad­der can­cer (NIM­BC) who haven’t un­der­gone cys­tec­tomies and are re­sis­tant to the stan­dard treat­ment. The bi­o­log­ics li­cense ap­pli­ca­tion will be dis­cussed at the FDA on­col­o­gy drug meet­ing on De­cem­ber 17, Mer­ck said, and has a PDU­FA date for next month, Jan­u­ary 2020.

The ex­pe­dit­ed re­view is based on KEYNOTE-057, a sin­gle-arm Phase II study that found 40 out of 102 pa­tients had a com­plete re­sponse at three months. Of those, 29 (72.5%) re­mained tu­mor-free through the last check-up at 14 months. Da­ta were not pre­sent­ed on par­tial re­spons­es.

The news comes two months af­ter the hype around Roche’s self-vaunt­ed Phase III da­ta on Tecen­triq in blad­der can­cer was bat­ted down by the com­pa­ny’s own in­ves­ti­ga­tors.

For once, though, Mer­ck might not find it­self with the most eye-catch­ing can­cer drug ap­proach­ing ap­proval. Last week, Fer­ring spun out a biotech built around a gene ther­a­py that us­es an ade­n­ovirus to de­liv­er the can­cer-sup­press­ing gene in­ter­fer­on al­fa-2b in­to blad­der walls. Fer­Gene, as the new com­pa­ny is known, hasn’t an­nounced a PDU­FA date, but the drug al­so has pri­or­i­ty re­view and the biotech has $570 mil­lion in back­ing.

Keytru­da first gained ap­proval in a blad­der can­cer, ad­vanced urothe­lial car­ci­no­ma, in 2017. That in­di­ca­tion was al­most re­ject­ed by UK health au­thor­i­ty NICE, though, who saw it as po­ten­tial­ly too cost­ly for an end-of-life treat­ment but ul­ti­mate­ly okayed the drug in 2018.

Blad­der can­cer has long been treat­ed by an old­er form of im­munother­a­py: Bacil­lus Cal­mette-Guérin, a bac­te­r­i­al strain com­mon­ly used as a tu­ber­cu­lo­sis vac­cine, and which ap­pears to trig­ger an im­mune re­sponse in the blad­der that can af­fect tu­mors. NIM­BC pa­tients rep­re­sent 75% of the an­nu­al 80,000 new blad­der can­cer cas­es in the US, ac­cord­ing to com­pa­ny-cit­ed es­ti­mates.

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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#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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