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.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.