No­var­tis just boast­ed of a big PhI­II PI3K suc­cess, but here’s why we should hold our ap­plause — for now

Just a few weeks af­ter No­var­tis $NVS punt­ed a po­ten­tial­ly dan­ger­ous PI3K drug out of its pipeline to a drug de­vel­op­er in Chi­na, the phar­ma gi­ant has come back with a pos­i­tive set of Phase III pro­gres­sion-free sur­vival da­ta on an­oth­er con­tender in this dicey can­cer drug field. And now No­var­tis says it will start knock­ing on reg­u­la­to­ry doors as it be­gins the ap­proval process.

All we have in this first cut is the head­line ma­te­r­i­al: The drug hit on the PFS pri­ma­ry end­point, with a com­bi­na­tion of BYL719 (alpelis­ib) and ful­ves­trant out­per­form­ing ful­ves­trant alone in a sta­tis­ti­cal­ly sig­nif­i­cant fash­ion for “hor­mone-re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor-2 neg­a­tive (HR+/HER2-) PIK3CA-mu­tant ad­vanced or metasta­t­ic breast can­cer that pro­gressed on or fol­low­ing aro­matase in­hibitor treat­ment with or with­out a CDK4/6 in­hibitor.”

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