MU­NICH — PI3K in­hibitors have had their prob­lems over the years, fail­ing some stud­ies, prov­ing to be dis­ap­point­ing in terms of dura­bil­i­ty in oth­ers. But No­var­tis $NVS be­lieves it may have come up with part of the an­swer with its lat­est da­ta on BYL719 (alpelis­ib) in com­bi­na­tion with ful­ves­trant.

Their al­pha-spe­cif­ic drug for PIK3CA mu­tat­ed HR+/HER2- ad­vanced breast can­cer, BYL719 plus ful­ves­trant near­ly dou­bled the pro­gres­sion-free sur­vival times for pa­tients, hit­ting 11 months com­pared to 5.7 months for a con­trol arm treat­ed on­ly with ful­ves­trant.

Fab­rice An­dré, the re­search di­rec­tor and head of IN­SERM Unit U981, called the re­sults the da­ta the “most en­cour­ag­ing” re­sults seen to date in this pa­tient group.

Rough­ly 40% of HR+ ad­vanced breast can­cer pa­tients have a PIK3CA mu­ta­tion, mak­ing this a sig­nif­i­cant piece of the over­all mar­ket.

The da­ta were re­leased over the week­end at ES­MO18.

An­dré says this drug is a stand­out, per­haps be­cause it is al­pha spe­cif­ic. Due to low­er tox­i­c­i­ty, the ma­jor­i­ty of the pa­tients can re­main on ther­a­py longer, he adds, which would ex­plain their hope for achiev­ing more durable re­spons­es than what’s been seen in oth­er PI3K pro­grams.

No­var­tis is now look­ing to fol­low up with talks at key reg­u­la­to­ry groups about an OK.

No­var­tis has had its is­sues with PI3K be­fore. The Swiss com­pa­ny hand­ed world­wide com­mer­cial rights to the late-stage bu­parlis­ib to one of Chi­na’s new up­start biotechs — rais­ing some thorny is­sues about how ques­tion­able drug as­sets may be passed to new play­ers for a com­mer­cial roll­out.

And Roche de­cid­ed to scrap its con­tender taselis­ib last June af­ter in­ves­ti­ga­tors re­port­ed a slight, 2-month pro­gres­sion-free sur­vival ad­van­tage for the drug — along with a sketchy safe­ty pro­file com­mon to the class — com­bined with ful­ves­trant hor­mone ther­a­py in a Phase III study of metasta­t­ic breast can­cer. 

No­var­tis, though, be­lieves it has grounds for an ap­proval, based large­ly on the speci­fici­ty of the drug.

“We are ex­cit­ed about the mean­ing­ful re­sults seen in SO­LAR-1 and about the pos­si­bil­i­ty to reimag­ine what po­ten­tial treat­ment op­tions could look like for pa­tients liv­ing with PIK3CA mu­tat­ed HR+/HER2- ad­vanced breast can­cer – some of who were pre­vi­ous­ly treat­ed with a CDK4/6 in­hibitor,” said Samit Hi­rawat, the head of No­var­tis On­col­o­gy Glob­al Drug De­vel­op­ment. “We are ac­tive­ly en­gag­ing in dis­cus­sions on these re­sults with health au­thor­i­ties world­wide.”

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.

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.