San­dra Horn­ing

CHICA­GO — Roche her­ald­ed a suc­cess for its close­ly-watched com­bi­na­tion breast can­cer study of Per­je­ta and Her­ceptin at AS­CO on Mon­day, but once the da­ta came in­to fo­cus there didn’t seem to be much to cheer about at the phar­ma gi­ant.

The two drugs to­geth­er per­formed bet­ter than Her­ceptin alone in im­prov­ing pa­tients’ odds of pre­vent­ing a re­cur­rence of the dis­ease — by a mar­gin of 0.9%. Af­ter three years of ther­a­py the score was 94.1% sur­vival in the com­bo arm with a 93.2% score for Her­ceptin.

“The goal of ad­ju­vant treat­ment is to help each per­son with can­cer have the best chance of a cure, and we come clos­er to this goal with each ad­vance,” said San­dra Horn­ing, chief med­ical of­fi­cer and head of glob­al prod­uct de­vel­op­ment. “In the APHIN­I­TY study, the Per­je­ta-based reg­i­men im­proved up­on the high bar set by Her­ceptin in peo­ple with HER2-pos­i­tive ear­ly breast can­cer. We look for­ward to work­ing with glob­al health au­thor­i­ties to bring this treat­ment op­tion to pa­tients.”

The new cock­tail ap­proach will cost sig­nif­i­cant­ly more than Her­ceptin alone, and that won’t sit well with pay­ers. Roche had been hop­ing to shore up its block­buster Her­ceptin fran­chise as that drug faces biosim­i­lar com­pe­ti­tion.

The big win­ner in all this? Puma Biotech, which saw its shares $PBYI shoot up 18% Mon­day morn­ing.

Their new drug ner­a­tinib demon­strat­ed a 34% re­duc­tion in the risk of re­cur­rence or death. It takes a leap to do these kinds of cross-tri­al analy­ses that dri­ve drug de­vel­op­ers a tad crazy now and then, but Wall Street an­a­lysts were quick to give Puma a thumbs up, par­tic­u­lar­ly af­ter it just hand­i­ly won an FDA pan­el vote en­dors­ing an ap­proval.

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.