Clo­vis soars as a new round of PhI­II Rubra­ca da­ta looks promis­ing — but ro­ci scan­dal bites again with $142M set­tle­ment

Shares of Clo­vis On­col­o­gy soared 50% Mon­day morn­ing, af­ter the biotech re­port­ed a sol­id slate of pro­gres­sion-free sur­vival da­ta for its PARP drug Rubra­ca (ru­ca­parib) that will help it line up right along­side ri­vals in the field, pos­si­bly elim­i­nat­ing an ad­van­tage held by Tesaro for ac­cess to a wider group of ovar­i­an can­cer pa­tients.

Soon af­ter the da­ta hit, though, Clo­vis re­vealed in an SEC fil­ing that it had ten­ta­tive­ly reached a deal to set­tle a class ac­tion law­suit brought by share­hold­ers af­ter Clo­vis’ dis­as­trous set­back on rocile­tinib, re­ject­ed by the FDA af­ter ques­tions arose about the dodgy da­ta that had been cir­cu­lat­ed about that can­cer ther­a­py ahead of the FDA’s de­ci­sion. The biotech is set­ting aside $142 mil­lion in cash and stock to set­tle al­le­ga­tions that it ac­tive­ly mis­led in­vestors on ro­ci. And Clo­vis al­so dis­closed that it is un­der in­ves­ti­ga­tion by the SEC as well as the Jus­tice De­part­ment over the ro­ci case.

Rubra­ca, though, looks bet­ter than ever.

In­ves­ti­ga­tors re­port­ed that the drug hit all three pri­ma­ry end­points for pro­gres­sion-free sur­vival in tu­mor BR­CA-mu­tant, HRD-pos­i­tive and over­all in­tent-to-treat pop­u­la­tions. It al­so hit a key sec­ondary end­point for an in­de­pen­dent re­view of those re­sults.

If it all holds up at the FDA, the da­ta should pave the way to broad­er use of the drug, Clo­vis’ on­ly mar­ket­ed ther­a­py. And it may well end up eat­ing in­to Tesaro’s mar­ket share, a point that helped dri­ve down its shares by 8% this morn­ing.

Clo­vis says that it will file a sup­ple­men­tal ap­pli­ca­tion “with­in the next four months for a sec­ond-line and lat­er main­te­nance treat­ment in­di­ca­tion for all women with plat­inum-sen­si­tive ovar­i­an can­cer who have re­spond­ed to their most re­cent plat­inum ther­a­py.”

The new da­ta comes as mar­ket leader As­traZeneca, with Lyn­parza, lines up to com­pete with Clo­vis and Tesaro with com­pa­ra­ble PARPs. It al­so adds pres­sure on Pfiz­er, which picked up a PARP in its $14 bil­lion Medi­va­tion buy­out, which con­tin­ues to look like a heav­i­ly in­flat­ed price for the as­sets the phar­ma gi­ant net­ted in the deal.

Leerink’s Michael Schmidt says he was im­pressed by Rubra­ca’s lat­est per­for­mance. He not­ed:

The re­sults look par­tic­u­lar­ly im­pres­sive when com­pared to pre­vi­ous com­peti­tor da­ta and we think should sup­port a broad la­bel for Rubra­ca in a broad 2L main­te­nance pa­tient pop­u­la­tion, in­de­pen­dent of BR­CA/HRD sta­tus and test­ing. We re­cent­ly ini­ti­at­ed cov­er­age of CLVS with an OP rat­ing (LINK). The top-line da­ta re­port­ed this morn­ing clear­ly re­flect the best-case out­come for CLVS high­light­ed in our pri­or re­port in­di­cat­ing that ef­fi­ca­cy of the 3 lead­ing PARP in­hibitors looks very com­pa­ra­ble and we ex­pect shares to trade up sig­nif­i­cant­ly. With best-case da­ta in hand, we think CLVS should be a prime take­out can­di­date, and we re­it­er­ate our OP rat­ing on the stock.

Over the last few weeks we’ve been treat­ed to a num­ber of stores about Tesaro’s auc­tion to sell the com­pa­ny. As to­day’s news about the PFS da­ta spreads, that could put a crimp on the high end of the mar­ket val­u­a­tions be­ing ap­plied to its drug, Ze­ju­la.

Clo­vis, mean­while, is find­ing it hard to put the ro­ci scan­dal be­hind it. The biotech was forced to re­state its da­ta sub­mit­ted for an ap­proval of rocile­tinib, prompt­ing an em­bar­rass­ing and dev­as­tat­ing drop in the num­ber of re­spons­es that the biotech had claimed for their drug. An FDA pan­el sub­se­quent­ly re­ject­ed the drug, fol­lowed by a for­mal re­jec­tion by the agency, prompt­ing Clo­vis to re­struc­ture and lay off staffers while bury­ing ro­ci as a los­er. Share­hold­ers filed dozens of law­suits as a re­sult, forc­ing the com­pa­ny to go on the de­fen­sive. Clo­vis had ear­li­er not­ed in SEC fil­ings that it was un­der fed­er­al in­ves­ti­ga­tion, but had not dis­closed who was han­dling the probe.

“Based on these en­cour­ag­ing da­ta, it is clear that ru­ca­parib demon­strates a clin­i­cal­ly mean­ing­ful im­pact in de­lay­ing dis­ease re­cur­rence in women in this tri­al with ad­vanced ovar­i­an can­cer,” said Robert Cole­man, the prin­ci­pal in­ves­ti­ga­tor for the ARIEL3 study. “The PFS and safe­ty re­sults achieved in this study are par­tic­u­lar­ly promis­ing, be­cause they sug­gest women are able to stay on ru­ca­parib for a pro­longed pe­ri­od of time while gain­ing ben­e­fit. It is al­so clin­i­cal­ly sig­nif­i­cant that ru­ca­parib not on­ly sus­tained the most re­cent re­sponse to plat­inum, but in some pa­tients al­so en­hanced that re­sponse, in­clud­ing the elim­i­na­tion of resid­ual tu­mor.”

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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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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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.