In a rare set­back, Mer­ck has suf­fered a key Phase III fail­ure for Keytru­da that could put a crimp in its sales prospects.

Roy Baynes

The phar­ma gi­ant re­port­ed af­ter the mar­ket closed on Tues­day that Keytru­da failed the KEYNOTE-240 study for he­pa­to­cel­lu­lar car­ci­no­ma, the most com­mon type of liv­er can­cer. The tri­al missed on both over­all sur­vival as well as pro­gres­sion-free sur­vival. That news ar­rived just 3 months af­ter the FDA of­fered an ac­cel­er­at­ed ap­proval on liv­er can­cer based on their ear­li­er mid-stage da­ta for the drug. 

Stay­ing on the mar­ket re­quires Mer­ck to put up pos­i­tive piv­otal da­ta. Ques­tions about the drug’s fu­ture in liv­er can­cer dinged Mer­ck’s stock $MRK, which dropped slight­ly more than 1% af­ter the re­lease hit.

Mer­ck was quick to note that it’s study­ing Keytru­da in a range of oth­er liv­er can­cer stud­ies, but the ad­van­tage here has clear­ly switched to Op­di­vo for now, which has been drag­ging steadi­ly be­hind Keytru­da af­ter falling short on lung can­cer, where Mer­ck holds first-line ad­van­tage.

This wasn’t the on­ly con­fir­ma­to­ry Phase III study to flop. Just weeks ago Eli Lil­ly had to sus­pend mar­ket­ing of Lartru­vo af­ter its piv­otal for soft tis­sue sar­co­ma failed. These back-to-back set­backs, though, are un­like­ly to slow down the FDA, which has proved ea­ger to hand out ac­cel­er­at­ed OKs — par­tic­u­lar­ly for can­cer drugs — in re­cent years.

“While we are dis­ap­point­ed KEYNOTE-240 did not meet its co-pri­ma­ry end­points, the re­sults for over­all sur­vival, pro­gres­sion-free sur­vival and ob­jec­tive re­sponse rate are gen­er­al­ly con­sis­tent with find­ings from the Phase II study, KEYNOTE-224, which led to the ac­cel­er­at­ed ap­proval of KEYTRU­DA for the treat­ment of pa­tients with he­pa­to­cel­lu­lar car­ci­no­ma who have been pre­vi­ous­ly treat­ed with so­rafenib,” said Roy Baynes, se­nior vice pres­i­dent and head of glob­al clin­i­cal de­vel­op­ment, chief med­ical of­fi­cer, Mer­ck Re­search Lab­o­ra­to­ries.

Pho­to cred­it: AP Im­ages.

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.

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.

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.