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. 

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.