No­var­tis CEO Vas Narasimhan is rais­ing the bar on sec­ond-gen can­cer drug stud­ies

No­var­tis $NVS has been no­tice­ably ab­sent from the cen­ter ring of PD-1/L1 re­search, qui­et­ly ad­vanc­ing its own check­point as an in-house as­set to match up with a grow­ing pipeline of can­cer ther­a­pies. But that doesn’t mean that new­ly pro­mot­ed CEO Vas Narasimhan hasn’t been think­ing a lot about the phar­ma gi­ant’s de­vel­op­ment strat­e­gy or what it has to do to po­si­tion it­self as the in­dus­try faces read­outs on a tsuna­mi of more than 1,000 com­bi­na­tion stud­ies now in the clin­ic.

In a con­ver­sa­tion with an­a­lysts for the Q1 re­view, Narasimhan made these com­ments on I/O:

I think there is of course very im­pres­sive da­ta and cer­tain­ly from the PD-1 from one of our com­peti­tors (that’s a ref­er­ence to Mer­ck’s Keytru­da/chemo com­bo), which I think is trans­for­ma­tive for pa­tients in lung can­cer. So, it’s a great thing in gen­er­al for so­ci­ety and for pa­tients. 

And then he moved on to sec­ond-gen­er­a­tion on­col­o­gy as­sets and I/O, where the CEO sees a ris­ing set of stan­dards on what it’s go­ing to take to demon­strate a suc­cess.

We eval­u­ate our sec­ond-gen­er­a­tion as­sets now at a high­er bar. We…in­creas­ing­ly want to en­sure that we have ap­pro­pri­ate con­trol arms so that we can see whether or not the com­bi­na­tion is hav­ing an im­pact on top of the PD-1 mono.

And I think one of the things we’re al­so putting a very heavy lens on: 

Do we have sin­gle-agent ac­tiv­i­ty? Be­cause I think sin­gle agent ac­tiv­i­ty will in­crease the like­li­hood that whether in com­bi­na­tion or not we might have a med­i­cine that’s go­ing to mat­ter. We eval­u­ate and have a high­er bar on what we progress. 

The nice thing for us in on­col­o­gy is we have a broad set of plat­forms. We are a leader in tar­get­ed ther­a­py. You see that in Mekin­ist and Tafin­lar as well as a leader in non­ma­lig­nant hema­tol­ogy as you see with Pro­mac­ta, Revolade, Ex­jade and Jakavi. So, we have that strong po­si­tion.

Sec­ond, we are a leader in CAR-T. We have Kym­ri­ah we have a broad port­fo­lio of CAR-Ts com­ing be­hind that. So, we have that as a plat­form. We have im­muno-on­col­o­gy, we have the 20 or so as­sets that are in the clin­ic eval­u­at­ing them, but we’ll take a stronger look at them. And then we brought in ra­dionu­clide ther­a­py (Lu­tathera), trans­for­ma­tive in neu­roen­docrine tu­mors. We’ll see how it un­folds in prostate can­cer, al­so look­ing at gas­tric can­cers. So, we are strate­gi­cal­ly try­ing to take a broad po­si­tion. 

We’re not over­ex­posed to I/O per se. And it’s not a bi­na­ry event for us whether I/O pans out for the com­pa­ny.


Im­age: Vas Narasimhan. NO­VAR­TIS

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
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Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.