Mi­rati wins over a Chi­nese part­ner for KRAS hope­ful, look­ing to tail Am­gen's break­through win

In a gun­shot heard across on­col­o­gy, the FDA hand­ed Am­gen a break­through win for a first-of-its-kind KRAS in­hibitor — once con­sid­ered “un­drug­gable” — late last week. The drug’s biggest com­peti­tor, not con­tent to rest on its lau­rels, has now signed a ma­jor mar­ket­ing deal in Chi­na as it eyes a fil­ing of its own.

Mi­rati will take home $65 mil­lion in cash and up to $273 mil­lion in biobucks from Chi­na’s Zai Lab for an ex­clu­sive li­cense to KRAS-G12C hope­ful ada­gra­sib in the Greater Chi­na re­gion, the com­pa­nies said Tues­day. The deal will al­so come with roy­al­ties worth some­where in the “high-teens to low-twen­ties-per­cent.”

Mi­rati will hold an op­tion to co-com­mer­cial­ize ada­gra­sib in Chi­na if it so choos­es and re­tains full com­mer­cial rights else­where. Zai Lab will al­so help dri­ve en­roll­ment in reg­is­tra­tion en­abling glob­al stud­ies for the drug.

Charles Baum

Earn­ing the sup­port of one of Chi­na’s biggest on­col­o­gy play­ers bodes well for Mi­rati’s goals to plant its flag in the re­gion, where lung can­cer killed near­ly three-quar­ters of a mil­lion peo­ple in 2020, ac­cord­ing to the World Health Or­ga­ni­za­tion. Zai Lab’s ex­pe­ri­ence in bring­ing on­col­o­gy as­sets to mar­ket was a draw for Mi­rati.

“Zai Lab has an es­tab­lished record of rapid and high qual­i­ty de­vel­op­ment and com­mer­cial­iza­tion of in­no­v­a­tive on­col­o­gy prod­uct can­di­dates in Chi­na,” Mi­rati CEO Charles Baum said in a re­lease. “Their ca­pa­bil­i­ties po­si­tion Mi­rati to fur­ther de­vel­op ada­gra­sib for pa­tients with can­cer who har­bor the KRASG12C mu­ta­tion around the world.”

In­vestor Brad Lon­car summed up the dy­nam­ics be­hind the tie-up best on Twit­ter:

Mi­rati has nipped at Am­gen’s heels in the race for the first small-mol­e­cule KRAS in­hibitor, but as of Fri­day, the biotech will of­fi­cial­ly chase the drug­mak­er to mar­ket af­ter the FDA gave a land­mark nod to Lumakras (so­tora­sib). Mi­rati has long tout­ed its drug’s su­pe­ri­or da­ta — par­tic­u­lar­ly in col­orec­tal can­cer, where Am­gen’s drug has shown lim­it­ed promise — but with two Phase III tri­als still re­cruit­ing, it could take a bit for that ad­van­tage to play out. Mi­rati plans to sub­mit its NDA as soon as the end of 2021.

The FDA based its Lumakras ap­proval on da­ta from Phase II CODE­BREAK100 study show­ing so­tora­sib post­ed a 36% over­all re­sponse rate among 124 pa­tients with ad­vanced NSCLC. There were three com­plete re­spons­es and 43 par­tials, with a me­di­an du­ra­tion of re­sponse of 10 months. Pro­gres­sion-free sur­vival hit 6.8 months.

How­ev­er, re­sults in oth­er tu­mor types were less than im­pres­sive. In a Phase I tri­al in col­orec­tal, so­tora­sib post­ed just a 7.1% re­sponse rate, with the ma­jor­i­ty of the 42 pa­tients in the tri­al had re­ceived at least three pri­or lines of ther­a­py. In oth­er tu­mors out­side of NSCLC and col­orec­tal, the drug fared even worse, with just three of 22 pa­tients show­ing par­tial re­spons­es sev­en weeks af­ter treat­ment.

Mean­while, ada­gra­sib hit a 43% re­sponse rate in a Phase I/Ib test in NSCLC with a me­di­an treat­ment du­ra­tion of 8.2 months as of an Oc­to­ber up­date. Half of that study’s pa­tients were still on ther­a­py, and five of six re­spon­ders were still re­spond­ing to the drug.

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