As­traZeneca, Mer­ck her­ald PhI­II prostate can­cer win for Lyn­parza — over­tak­ing Clo­vis, J&J in PARP race

The case for ex­pand­ing Lyn­parza’s use just got stronger as As­traZeneca and Mer­ck claim a late-stage suc­cess in ex­tend­ing the time prostate can­cer pa­tients live with­out pro­gress­ing com­pared to stan­dard of care.

Ri­vals at Clo­vis pro­vid­ed the first re­sound­ing ev­i­dence that PARP in­hibitors could be pow­er­ful against metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer last Oc­to­ber, when it un­veiled at ES­MO that Rubra­ca in­duced a 44% con­firmed ob­jec­tive re­sponse rate among 25 sec­ond-line pa­tients with a BR­CA al­ter­ation. Days pri­or to the pre­sen­ta­tion, the Phase II da­ta had earned the biotech a “break­through” des­ig­na­tion at the FDA.

José Basel­ga As­traZeneca

As­traZeneca and Mer­ck took it a step fur­ther with their Phase III re­sults, tout­ing “a sta­tis­ti­cal­ly-sig­nif­i­cant and clin­i­cal­ly-mean­ing­ful im­prove­ment in the pri­ma­ry end­point of ra­di­ograph­ic pro­gres­sion-free sur­vival (rPFS).” No num­bers were avail­able with the top-line an­nounce­ment, but the phar­ma part­ners em­pha­size it’s a first in the PARP class for this in­di­ca­tion, where the need is high.

“For men with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer the dis­ease re­mains dead­ly, es­pe­cial­ly in those who have failed on a new hor­mon­al an­ti­cancer treat­ment,” José Basel­ga, As­traZeneca’s head of on­col­o­gy R&D.

The 340 pa­tients re­cruit­ed in the PRO­found study are all con­firmed, via ge­nom­ic test­ing to har­bor mu­ta­tions in one of 15 ho­mol­o­gous re­com­bi­na­tion re­pair genes. They have al­so all pro­gressed fol­low­ing pri­or treat­ment with hor­mon­al ther­a­py.

In the open-la­bel tri­al, pa­tients were ei­ther giv­en Lyn­parza, en­za­lu­tamide or abi­raterone ac­etate.

In their analy­sis in­ves­ti­ga­tors ze­roed in on BR­CA1/2 — a key qual­i­fi­er for pre­vi­ous wins in ovar­i­an, breast and pan­cre­at­ic can­cers — and ATM gene mu­ta­tions. The ef­fects of Lyn­parza, which blocks a self-re­pair mech­a­nism adopt­ed by can­cer cells, on the oth­er pa­tient sub­groups re­main un­clear.

As­traZeneca re­port­ed Lyn­parza sales of $520 mil­lion in H1 2019, far ahead of the $66.1 mil­lion Clo­vis’ Rubra­ca man­aged to gar­ner in the same pe­ri­od. Ze­ju­la sales were around $120 mil­lion, and J&J (which li­censed rights to the prostate can­cer in­di­ca­tion from Tesaro back in 2016) has demon­strat­ed a 40% ORR in a Phase II study for the Glax­o­SmithK­line drug. Clo­vis plans to sub­mit an NDA in the fourth quar­ter of this year.

Mean­while, Mer­ck has kicked off an um­brel­la study pair­ing its PD-1 star Keytru­da with a num­ber of oth­er agents, in­clud­ing Lyn­parza, for prostate can­cer, with an am­bi­tion to move to the front­line.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.