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.” 

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.

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.