The da­ta on As­traZeneca’s Phase III Imfinzi tri­al are out, and it bodes well for the UK out­fit’s bid to get their sig­na­ture im­munother­a­py ap­proved for front­line small-cell lung can­cer (SCLC).

Pa­tients re­ceiv­ing the PD-L1 Imfinzi (along­side a stan­dard chemother­a­py reg­i­men) in As­traZeneca’s CASPI­AN study sur­vived for 13 months on av­er­age, com­pared with 10.3 months for pa­tients re­ceiv­ing the stan­dard of care. Those num­bers com­pare fa­vor­ably to the re­sults of the piv­otal study that pushed Roche’s PD-L1 Tecen­triq across the fin­ish line. Tecen­triq pa­tients had an OS of 12.3 months in that study, which was an­nounced six months be­fore the FDA ap­proved the drug for front­line SCLC. 

In­ves­ti­ga­tors al­so tout­ed their drug’s dura­bil­i­ty, with 33.9% of pa­tients still alive at 18 months fol­low­ing treat­ment with Imfinzi plus chemother­a­py vs 24.7% of pa­tients fol­low­ing the stan­dard of care.

The study may prove a ma­jor boon for As­traZeneca in the heady race to ex­pand their mar­kets for PD-1/L1 drugs — and in the drug­mak­er’s steady growth in the lung can­cer mar­ket. Last year, its stand­out Tagris­so was ap­proved for front­line treat­ment of EGFR-mu­tat­ed non-small cell lung can­cer. And Imfinzi has seized an im­por­tant niche in the lung can­cer mar­ket with its ap­proval for stage III non-small cell lung can­cer.

Al­though it ac­counts for less than 20% of lung can­cer cas­es, SCLC re­mains par­tic­u­lar­ly dif­fi­cult to treat.

PD-1 and PD-L1 drugs work by in­hibit­ing pro­teins can­cer cells use to block T cells from at­tack­ing them. This makes them a prime fo­cus for on­col­o­gy re­search, and six PD-1/L1 im­munother­a­pies, both for SCLC and a slew of oth­er can­cers, have al­ready been ap­proved by the FDA, with a host of tri­als un­der­way to ex­pand their use. 

Mer­ck has been the leader in PD-1/L1 thus far, with its sig­na­ture drug Keytru­da pro­ject­ed to be a glob­al top-10 block­buster by 2024. 

For As­traZeneca, the Phase III CASPI­AN re­sults come as wel­come news af­ter its com­bi­na­tion of Imfinzi and treme­li­mum­ab failed tri­als for head and neck can­cer, and for an­oth­er form of lung can­cer. The study was con­duct­ed on 537 pa­tients re­ceiv­ing first-line treat­ment for non-small cell lung can­cer in over 200 cen­ters, across 22 coun­tries and four con­ti­nents. 

José Basel­ga As­traZeneca

“We are en­cour­aged to see more than a third of small cell lung can­cer pa­tients treat­ed with Imfinzi plus chemother­a­py alive at the 18-month land­mark, which is re­mark­able giv­en the ag­gres­sive na­ture of the dis­ease,” José Basel­ga, As­traZeneca’s ex­ec­u­tive vice pres­i­dent of on­col­o­gy R&D, said in a state­ment. 

Imfinzi, al­ready ap­proved for un­re­sect­ed stage III SCLC, is al­so be­ing test­ed with con­cur­rent chemother­a­py for lim­it­ed-stage SCLC in As­traZeneca’s Phase III ADRI­AT­IC tri­al. Roche an­nounced to­day it will con­duct a Phase I/II tri­al with KAHR med­ical to treat NSCLC pa­tients who are re­frac­to­ry, or re­sis­tant, to check­point in­hibitors. 

Cor­rec­tion: An ear­li­er ver­sion of this ar­ti­cle in­cor­rect­ly iden­ti­fied Mer­ck as Mer­ck KGaA. Ref­er­ences to Mer­ck KGaA have been re­moved. 

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.