Mer­ck and Bris­tol-My­ers Squibb aren’t the on­ly big play­ers look­ing to make a splash in front­line lung can­cer. Roche is al­so look­ing to el­bow in, and it’s of­fered up a look at some ad­di­tion­al IM­pow­er150 da­ta at AACR to back up their shot.

Alan San­dler

We al­ready know that Roche ex­ecs gave a pre­lim­i­nary thumbs up for its piv­otal IM­pow­er150 tri­al, study­ing a com­bi­na­tion of Tecen­triq, Avastin and chemo in front­line non­squa­mous non-small cell lung can­cer and hit­ting a haz­ard ra­tio of 0.62 for the full group of pa­tients in the study. Pro­gres­sion Free Sur­vival in the main group was a me­di­an 8.3 months com­pared to 6.8 months in the con­trol, a mar­gin­al gain which isn’t like­ly to stir much ex­cite­ment. 

We’re find­ing out at AACR, though, that the line­up of ther­a­pies al­so stood out in some key sub­groups with par­tic­u­lar­ly en­cour­ag­ing pro­gres­sion-free sur­vival da­ta.

Look­ing at one EGFR/ALK+c sub­group, Roche is re­port­ing a me­di­an pro­gres­sion-free sur­vival rate of 9.7 months — and a haz­ard ra­tion of 0.59 — com­pared to the con­trol arm with a 6.1 month PFS rate. Among 59 pa­tients in the EGFR ex­on 19 dele­tion of L858R group the haz­ard ra­tio hit 0.42, with a 10.2 month PFS com­pared to 6.1 months. And in pa­tients with liv­er metas­tases the PFS was 8.2 months com­pared to 5.4 months, with an HR of 0.40. In pa­tients with­out liv­er metas­tases, the HR jumps to 0.64.

Those kinds of num­bers in these par­tic­u­lar sub­groups are huge­ly im­por­tant, says Alan San­dler, glob­al head of the lung can­cer fran­chise at Genen­tech, as this is the first time in­ves­ti­ga­tors are get­ting a close look at these pa­tients’ re­sponse.

San­dler al­so not­ed that they saw pos­i­tive re­sults for both low and high PD-L1 ex­pressers, un­der­scor­ing a trend where the high ex­pressers are like­ly to see an en­hanced ben­e­fit from lung can­cer com­bos, with low ex­pressers still gain­ing a sig­nif­i­cant re­sponse as well.

I talked to San­dler ahead of the post­ing at AACR. One ob­jec­tion that’s been raised to the three-drug reg­i­men is that it adds a cost­ly ther­a­py to the mix. But he doesn’t think that price will be a bar­ri­er to fu­ture use.

“If there’s a clin­i­cal ben­e­fit,” says San­dler, “there will be us­age.”

There are al­so plen­ty of ways that a price on a par­tic­u­lar com­bi­na­tion can be worked so that there isn’t nec­es­sar­i­ly a cost hur­dle to over­come, he adds.

Roche still has fur­ther to go in col­lect­ing more ma­ture sur­vival da­ta from the study. That will ar­rive at a fu­ture con­fer­ence. But they’re in the mix to­day, even as Mer­ck steals the show with its Keytru­da/chemo com­bo.

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.