Mer­ck KGaA, Pfiz­er's Baven­cio set to seal blad­der can­cer ap­proval af­ter con­fir­ma­to­ry tri­al scores

Baven­cio could use the win.

More than two years af­ter its mak­ers — Ger­many’s Mer­ck KGaA and Pfiz­er — se­cured FDA ap­proval for a form of blad­der can­cer, the com­pa­nies un­veiled that the con­fir­ma­to­ry study test­ing the PD-L1 in­hibitor had per­formed as ex­pect­ed, help­ing pa­tients live longer as a main­te­nance treat­ment ver­sus stan­dard-of-care.

The drug was grant­ed ac­cel­er­at­ed ap­proval on the ba­sis of tu­mor re­sponse and du­ra­tion of re­sponse in May 2017 in pa­tients with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma (UC) whose dis­ease has pro­gressed dur­ing or af­ter plat­inum-con­tain­ing chemother­a­py. On Mon­day, the com­pa­nies said that da­ta from the con­fir­ma­to­ry JAVELIN Blad­der 100 tri­al showed pa­tients treat­ed with Baven­cio lived sig­nif­i­cant­ly longer than those who re­ceived stan­dard care.

A sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival was demon­strat­ed in the Baven­cio arm in each of the co-pri­ma­ry pop­u­la­tions: all ran­dom­ized pa­tients and pa­tients with PD-L1–pos­i­tive tu­mors, the com­pa­ny added, with­out dis­clos­ing the num­bers. The da­ta will be hand­ed over to the FDA.

Baven­cio was late to the check­point in­hibitor game. Mer­ck’s mar­ket-lead­ing Keytru­da and Bris­tol-My­ers’ pi­o­neer­ing Op­di­vo were the first two PD-1/L1 drugs to make the cut, and have since scored var­i­ous ap­provals across im­muno-on­col­o­gy and now reap in bil­lions in sales. Re­gen­eron, Roche and Chi­na-based drug de­vel­op­ers al­so have their own check­points — PARP in­hibitors are al­so the mix.

Last Sep­tem­ber, Cowen an­a­lysts shaved their 2024 pro­jec­tions for Baven­cio by $170 mil­lion to $480 mil­lion, cit­ing flat growth and rel­a­tive­ly few cat­a­lysts ahead. In com­par­i­son, Op­di­vo is ex­pect­ed to gen­er­ate a meaty $12.4 bil­lion that year, and king Keytru­da a hefty $20.6 bil­lion, the an­a­lysts es­ti­mat­ed.

Baven­cio, for which Pfiz­er paid $850 mil­lion up­front in 2014 to part­ner with Mer­ck KGaA on, has had some se­ri­ous set­backs in its quest to make a mark. The part­ners were forced to ad­mit de­feat in ovar­i­an can­cer in March last year af­ter three straight tri­al fail­ures. Months lat­er in No­vem­ber, the drug al­so fiz­zled as a first-line main­te­nance ther­a­py for gas­tric can­cer pa­tients, years af­ter fal­ter­ing in a gas­tric can­cer study to im­prove over­all sur­vival. In 2018, Baven­cio al­so botched a key study in the lu­cra­tive field of lung can­cer.

The com­pa­nies, how­ev­er, did have some luck in kid­ney can­cer. Baven­cio was grant­ed ap­proval in May 2019 in com­bi­na­tion with Pfiz­er’s ty­ro­sine ki­nase in­hibitor In­ly­ta for use as a front­line ther­a­py for re­nal cell car­ci­no­ma, af­ter late-stage da­ta showed the com­bi­na­tion demon­strat­ed a sig­nif­i­cant pro­gres­sion-free sur­vival ben­e­fit. It is al­so ap­proved for use in Merkel cell car­ci­no­ma.

UC ac­counts for about 90% of all blad­der can­cer cas­es. When blad­der can­cer is metasta­t­ic, the five-year sur­vival rate is 5%, ac­cord­ing to Amer­i­can Can­cer So­ci­ety es­ti­mates.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Once a gem, now just a rock, Take­da punts PhI­II IBD drug as ri­vals mus­cle ahead

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.