Can­cer drug ri­vals at Loxo and Blue­print go toe-to-toe once again, and one an­a­lyst scores a (pos­si­ble) win on points

Who’s ready to start the week com­par­ing da­ta on two ri­val can­cer drugs from stud­ies fea­tur­ing dif­fer­ent tri­al de­signs?

OK, I’ll do it any­way.

Loxo On­col­o­gy $LOXO and Blue­print Med­i­cines $BPMC have been duk­ing it out with their ear­ly-stage stud­ies on their RET in­hibitors, and they were both back at it with up­dates for mu­tant medullary thy­roid can­cer at the Amer­i­can Thy­roid As­so­ci­a­tion meet­ing over the week­end.

An­drew Berens

Leerink’s An­drew Berens scored the two lat­est snap­shots on da­ta, and I’ll let him do the sum­ma­ry. First, though, I’ll echo Berens’ note that the two drugs are not dosed the same way, with Loxo pa­tients able to get a dose es­ca­la­tion dur­ing the study, while Blue­print is stick­ing with a fixed-dose study — which may put it at a dis­ad­van­tage in terms of quick com­par­isons.

Purists in the field hate these tri­al com­par­isons, but in­vestors eat them up.

That said, Loxo re­port­ed an up­dat­ed ORR of 59% for LOXO-292, with 2 com­plete re­spons­es and 15 par­tials. The ORR is up from the 45% re­port­ed at AS­CO while the 78% re­sponse rate seen for pa­tients with a RET fu­sion thy­roid can­cer is down a bit. Still, the an­a­lyst notes, the up­date on­ly ac­counts for 9 pa­tients in to­tal, so don’t try to read too much in­to that.

Blue­print, which has suf­fered be­fore from the side-by-side pics with BLU-667, had a 49% re­sponse rate with 1 CR and 16 PRs. Berens: “In­ter­est­ing­ly, re­spons­es ap­pear to be deep­en­ing over time. ORR for pa­tients treat­ed at 300/400mg QD dose lev­el was 35% at 8 weeks of treat­ment, 56% at 16 weeks and 62% at 24 weeks. Re­spons­es were equiv­a­lent in pa­tients with and with­out pri­or mul­ti-ki­nase in­hibitor (MKI) treat­ment (~50%). 83% (35/42) of thy­roid can­cer pa­tients re­main on treat­ment, and 100% of re­spon­ders (19/19) and those treat­ed at 400mg QD (14/14) re­main on ther­a­py.”

Sure, says Berens, Blue­print may well feel some heat be­cause its num­bers still don’t mea­sure up to Loxo — now part­nered in a deal with Bay­er — but he gives both drugs a thumbs up for im­prov­ing re­sponse rates and im­pres­sive (ear­ly) signs of dura­bil­i­ty.

Did I say that this ri­val­ry has a ways to run?

For now, the hand­i­cap­ping con­tin­ues to fa­vor Loxo, but this race isn’t over. Al­so, there’s noth­ing in the Blue­print num­bers to sug­gest that they’re go­ing to be forced out of the race, with good chances that both get through a well greased reg­u­la­to­ry sys­tem — pro­vid­ed the da­ta hold up.

Loxo al­so got bonus points at the ATA meet­ing. Berens notes that they have “up­dat­ed da­ta for larotrec­tinib in sev­en pa­tients with TRK fu­sion thy­roid can­cer. Five of these pa­tients had pap­il­lary dis­ease, while one had fol­lic­u­lar, and one had anaplas­tic dis­ease. Six of the sev­en pa­tients re­main on ther­a­py, with du­ra­tion of treat­ment rang­ing from 12.9 months to 28.7 months.”

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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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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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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Roger Perlmutter, Merck R&D chief (YouTube)

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.

Ear­ly sur­vival da­ta boost Zio­phar­m's 'con­trolled IL-12' im­munother­a­py for glioblas­toma

An unconventional pairing of a gene therapy and an oral drug that promises to attack recurrent or progressive glioblastoma with controlled release of IL-12 has turned up more promising — if early — overall survival data. On top of boosting its case as a monotherapy, the data can also bode well for a combination with Regeneron’s PD-1 inhibitor, Libtayo.

Both the treatment and its developer, Ziopharm Oncology, have come a long way. The stock price peaked in 2015 but cratered in 2016 following a patient death in a Phase I.