As­traZeneca has sketched out some fresh de­tails on its mis­sion crit­i­cal piv­otal study on its check­point drug ap­proach to non-small cell lung can­cer, map­ping an­oth­er like­ly de­lay as the phar­ma gi­ant looks for its first big open­ing in the megablock­buster can­cer mar­ket.

The MYS­TIC study has been en­rolling lung can­cer pa­tients re­gard­less of PD-L1 ex­pres­sion sta­tus. In its state­ment to­day the phar­ma gi­ant says it will eval­u­ate pro­gres­sion-free sur­vival as well as over­all sur­vival for dur­val­um­ab com­bined with treme­li­mum­ab — its all-im­por­tant I/O + I/O matchup that will look to out­per­form the ther­a­pies al­ready ap­proved for front­line and sec­ond line pa­tients — for all com­ers as well as PD-L1 ex­pressers. And it will al­so now ex­plore the da­ta for dur­val­um­ab as a monother­a­py.

Sea­mus Fer­nan­dez, Leerink

Da­ta are ex­pect­ed now mid-year for PFS and no lat­er than some­time in 2018 for OS, which Sea­mus Fer­nan­dez at Leerink counts as a three-month de­lay:

“In the wake of MRK’s (MP) sur­prise fil­ing an­nounce­ment for its Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py com­bi­na­tion, AZN’s de­ci­sion to fo­cus on MYS­TIC’s best chance of suc­cess with ei­ther mono- or com­bo ther­a­py is ra­tio­nal, in our view,” Fer­nan­dez not­ed. “In ad­di­tion, the com­pa­ny’s strate­gic up­date on im­muno-on­col­o­gy (IO) monother­a­py (PEARL study) and com­bo ther­a­py (ex­pand­ed NEP­TUNE re­cruit­ment) pro­vides an­oth­er sub­stan­tial shot on goal for the com­pa­ny’s glob­al IO ef­forts.”

The NEP­TUNE study will be used to seek an OK in Chi­na for first-line use based on ear­li­er PFS da­ta while the new­ly launched PEARL will go af­ter PD-L1 ex­pressers in Asian mar­kets, where the rate of NSCLC runs high.

Mer­ck stunned the mar­ket re­cent­ly when it sped through a fil­ing for a com­bi­na­tion of Keytru­da with chemother­a­py in front­line NSCLC, putting some fresh dis­tance be­tween its big check­point and Bris­tol-My­ers Squibb’s ri­val Op­di­vo. Roche was the third play­er on the mar­ket with Tecen­triq, which is al­so in­volved in mul­ti­ple stud­ies.

As­traZeneca, which stum­bled through a se­ries of mishaps last year, des­per­ate­ly needs to do some­thing right with dur­val­um­ab to at least par­tial­ly sat­is­fy some big promis­es CEO Pas­cal So­ri­ot has made to in­vestors. A late ar­rival to the check­point mar­ket, ei­ther along­side or right be­hind Pfiz­er, leaves As­traZeneca with shrink­ing op­por­tu­ni­ties for mak­ing a splash.

It’s still pos­si­ble, though, and an­a­lysts aren’t count­ing the com­pa­ny out.

“While Keytru­da is now ap­proved in 1L pa­tients with PD-L1 ex­pres­sion of 50% or high­er, there re­mains “white space” for dur­va in PD-L1+ pa­tients with low­er (but still pos­i­tive) ex­pres­sion,” re­ports Fer­nan­dez.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.