Roche boasts of stalling lung can­cer with Tecen­triq/chemo com­bo -- but ri­val Mer­ck stays out front

CHICA­GO — Roche ar­rived at AS­CO boast­ing a sig­nif­i­cant ad­vance for treat­ing front­line cas­es of ad­vanced squa­mous non-small cell lung can­cer with a com­bi­na­tion of Tecen­triq and chemo. But the ad­van­tage it of­fers may ap­pear rel­a­tive­ly mar­gin­al for pa­tients and was quick­ly eclipsed by more ex­ten­sive pos­i­tive da­ta from a dom­i­nant Mer­ck.

We al­ready learned the top-line re­sults ear­li­er from the phar­ma gi­ant, which con­tin­ues to have high hopes for the PD-L1 check­point in­hibitor, even as it’s in dan­ger of los­ing its third-place po­si­tion be­hind Mer­ck and Bris­tol-My­ers Squibb to a surg­ing As­traZeneca.

Re­searchers came to Chica­go with some specifics on the da­ta, no­tably high­light­ing a dou­bling of pro­gres­sion-free sur­vival among large groups of pa­tients on the com­bo com­pared to chemo alone. 

Af­ter 12 months of treat­ment, can­cer had not wors­ened in 24.7% pa­tients get­ting the Tecen­triq/chemo com­bo com­pared to 12% for chemo alone. And that’s the first Phase III ad­van­tage that’s ap­peared for this group of pa­tients in the all-im­por­tant lung can­cer field.  Medi­an PFS was 6.3 months for the Roche check­point vs. 5.6 months for the con­trol — not the kind of gap that is like­ly to stir ex­cite­ment.

That like­ly cre­ates big trou­ble for Roche. Mer­ck re­leased its own read­out on pos­i­tive sur­vival da­ta on Sun­day from Keynote-407. Mer­ck is al­ready the PD-1 leader in treat­ing front­line lung can­cer, and Roche hasn’t changed those dy­nam­ics at AS­CO.

Daniel O’Day

What’s at stake?

Jef­feries has been ex­pect­ing to see $1.1 bil­lion of peak sales for Tecen­triq in this front­line squa­mous set­ting and pre­vi­ous­ly high­light­ed that a pos­i­tive re­sult from the tri­al could see 1%-3% up­side to EPS and val­u­a­tion.

There was no over­all sur­vival ben­e­fit vis­i­ble at this in­ter­im point of the Roche study as re­searchers re­port­ed me­di­an OS of 14 months for ate­zolizum­ab plus chemother­a­py vs. 13.9 months for chemother­a­py alone at this point. Re­searchers say they will have a fol­lowup OS read­out lat­er this year.

We’ll have to wait and see how that all fits in Roche phar­ma chief Daniel O’Day’s ex­pec­ta­tions that Roche “will di­men­sion­al­ize the first-line lung can­cer space in 2018.”

“Un­til now, there have been few treat­ment ad­vances for squa­mous non-small-cell lung can­cer. Our find­ings may pro­vide a new po­ten­tial treat­ment op­tion for this type of can­cer,” said lead study au­thor Robert Jotte. “We used to think that chemother­a­py just knocked down the pa­tient’s im­mune sys­tem and that it would be ir­ra­tional to com­bine it with im­munother­a­py, but grow­ing re­search, in­clud­ing this study, shows that chemother­a­py can help trig­ger the im­mune re­sponse to the tu­mor, help­ing the im­munother­a­py treat­ment work bet­ter.” 

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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