Clas­si­cal Hodgkin lym­phoma was the first blood can­cer that Mer­ck’s Keytru­da was ap­proved to treat. Three years af­ter that OK ar­rived — kick­ing off a spate of new in­di­ca­tions for the star PD-1 in­hibitor — the com­pa­ny fi­nal­ly has some sol­id ev­i­dence of its ef­fect.

Build­ing on the over­all re­sponse rates that con­vinced FDA reg­u­lars to hand down an ac­cel­er­at­ed ap­proval in March 2017, Mer­ck said Keytru­da hit a co-pri­ma­ry end­point on pro­gres­sion-free sur­vival in the Phase III con­fir­ma­to­ry tri­al.

The up­date comes from an in­ter­im analy­sis com­par­ing Keytru­da to Ad­cetris, an an­ti­body-drug con­ju­gate from Seat­tle Ge­net­ics, among pa­tients with re­lapsed or re­frac­to­ry cHL who have re­ceived three or more lines of ther­a­py.

“Pa­tients with clas­si­cal Hodgkin lym­phoma are gen­er­al­ly young and when they do not achieve re­mis­sion fol­low­ing stan­dard treat­ment, their can­cer is chal­leng­ing to treat,” Jonathan Cheng, VP of on­col­o­gy clin­i­cal re­search at Mer­ck Re­search Lab­o­ra­to­ries, said in a state­ment.

The study, KEYNOTE-204, will con­tin­ue to eval­u­ate the oth­er co-pri­ma­ry end­point of over­all sur­vival. Re­sults will be pre­sent­ed at an up­com­ing med­ical meet­ing.

Mer­ck in­clud­ed the monother­a­py reg­i­men in fourth-line treat­ment of cHL in its ap­pli­ca­tion for a new Keytru­da dos­ing sched­ule of every six weeks — to which the FDA re­spond­ed with a com­plete re­sponse let­ter days ago. But Mizuho an­a­lyst Mara Gold­stein char­ac­ter­ized it as one of the “less mean­ing­ful in­di­ca­tions” com­pared to core com­bo fran­chis­es in non-small cell lung can­cer and re­nal cell car­ci­no­ma in dri­ving sales of $20 bil­lion by 2024 as she has pre­vi­ous­ly es­ti­mat­ed.

The com­pa­ny has two oth­er cHL tri­als for Keytru­da un­der way, in­clud­ing com­bi­na­tion tests with chemo among chil­dren and young adults new­ly di­ag­nosed with the dis­ease (KEYNOTE-667), and with Af­fimed’s AFM13 in the post-Ad­cetris set­ting (KEYNOTE-206).

So­cial im­age: Shut­ter­stock

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.