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. 

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

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.