Roche scores a no­table PhI­II suc­cess with Tecen­triq com­bo in blad­der can­cer, but is this an­oth­er case of too lit­tle too late?

Two years af­ter Roche’s PD-L1 drug Tecen­triq failed a key test for front­line blad­der can­cer as a monother­a­py, in­ves­ti­ga­tors are back with Phase III ev­i­dence that their check­point tied to chemo can do some good for pa­tients.

San­dra Horn­ing

Their IMvig­or130 study came through on the co-pri­ma­ry end­point for pro­gres­sion-free sur­vival, but they’ll have to wait for the da­ta to ma­ture more be­fore they make the call on over­all sur­vival.

The da­ta will al­so be held back for a sci­en­tif­ic con­fer­ence, which is when we’ll get an idea on the im­pact this could have on rev­enue.

That’s a first in the check­point field. But it’s go­ing to be an up­hill climb for the phar­ma gi­ant.

Roche right now is one of the al­so-rans in the PD-(L)1 game, with Mer­ck’s Keytru­da surg­ing fur­ther and fur­ther ahead of the once-dom­i­nant team at Bris­tol-My­ers’ Op­di­vo. The oth­er 4 drugs on the mar­ket have been mak­ing very slow progress, rel­a­tive­ly, and there’s a whole new wave of ri­vals poised to hit Amer­i­can shores in the near term which will like­ly make things much worse for the sec­ond-tier play­ers.

Roche has a lot left to prove here. The com­pa­ny hit close to $450 mil­lion in rev­enue from Tecen­triq in Q2, mak­ing it a block­buster for the com­pa­ny — which has in­clud­ed this one as one of its bright­est new prospects. But Mer­ck, mean­while, reg­is­tered $2.6 bil­lion in Q2 sales, far out­strip­ping the rest of the field. And they’re pro­ject­ed to raise that to $17 bil­lion to $20 bil­lion in Ever­est-high peak sales.

“IMvig­or130 is the first pos­i­tive Phase III study of a can­cer im­munother­a­py com­bi­na­tion in pre­vi­ous­ly un­treat­ed ad­vanced blad­der can­cer, an ag­gres­sive dis­ease with high un­met need,” said San­dra Horn­ing, CMO. “These re­sults sup­port our broad clin­i­cal de­vel­op­ment pro­gram for Tecen­triq in blad­der can­cer, as well as our ap­proach of com­bin­ing im­munother­a­py with chemother­a­py or oth­er med­i­cines to im­prove pa­tient out­comes, and we look for­ward to dis­cussing them with health au­thor­i­ties.”

Tecen­triq Q2 up­date
Glob­al growth dri­ven by lung and breast fran­chis­es

CER=Con­stant Ex­change Rates; NSCLC=non-small cell lung can­cer; SCLC=small cell lung can­cer; TNBC=triple-neg­a­tive breast can­cer; HCC=he­pa­to­cel­lu­lar car­ci­no­ma (Source: Roche)

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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.