Forma takes aim at Agios with new AML complete remission data - Endpoints News

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For­ma Ther­a­peu­tics went pub­lic this year and raised $320 mil­lion in large part on the strength of their Phase I/II sick­le cell pro­gram. But their non-core pro­grams al­so held promise, in­clud­ing that they could go toe-to-toe with Agios on acute myeloid leukemia. To­day, the Mass­a­chu­setts biotech an­nounced they’ve done that — al­most to a tee.

On Tues­day, For­ma an­nounced that, in a piv­otal Phase II study, its AML drug olu­tasi­denib led to a com­plete re­mis­sion in 30% of re­lapsed or re­frac­to­ry IDH1m-pos­i­tive pa­tients. Com­bine that with a 3% rate of com­plete re­mis­sion with par­tial hema­to­log­ic re­cov­ery, and you get a 33% CR/CR+ rate — vir­tu­al­ly iden­ti­cal with the 32.7% CR/CR+ rate that Agios’ Tib­so­vo showed in a piv­otal study on these pa­tients.

Patrick Kel­ly

For­ma didn’t say how many pa­tients were in­clud­ed in the in­ter­im analy­sis, al­though the tri­al is slat­ed to en­roll 500 vol­un­teers over­all and the com­pa­ny said the first slice was large enough to sup­port an ap­pli­ca­tion for ap­proval. There wasn’t enough da­ta yet to de­ter­mine how long the re­mis­sions last­ed, but one sen­si­tiv­i­ty analy­sis in­di­cat­ed it was around 13.8 months.

With­out giv­ing the name of their ri­val, CMO Patrick Kel­ly claimed that fig­ure, along with the safe­ty pro­file, would al­low For­ma to un­seat Agios and Tib­so­vo as the cur­rent top ther­a­py.

“The safe­ty pro­file and the du­ra­tion of the re­sponse we’re see­ing sup­ports the po­ten­tial for olu­tasi­denib to be­come a lead­ing ther­a­py for R/R IDH1m AML pa­tients,” he said. “These ef­fi­ca­cy da­ta sup­port an ear­ly stop in en­roll­ment in fa­vor of mov­ing the pro­gram for­ward.”

If the du­ra­tion of re­sponse holds up, it would in­deed be a sig­nif­i­cant step up from Tib­so­vo, which pa­tients re­spond­ed to for a me­di­an of 8.2 months in its piv­otal tri­al. Tib­so­vo earned Agios $28 mil­lion in Q2, al­though that cov­ers both re­frac­to­ry and first-line pre­scrip­tions.

The tri­al suc­cess comes just as Agios suf­fers a set­back in AML, as the EMA with­drew ap­proval for the drug, ar­gu­ing that the 2018 sin­gle-arm tri­al that led to FDA ap­proval didn’t pro­vide suf­fi­cient ev­i­dence. For­ma’s piv­otal tri­al is larg­er but al­so not ran­dom­ized, so it re­mains un­clear how the EMA would view an ap­pli­ca­tion for the drug.

Agios is now fo­cused on ran­dom­ized-con­trolled stud­ies for front­line pa­tients el­i­gi­ble and in­el­i­gi­ble for in­ten­sive chemother­a­py. For­ma has an­nounced no ad­di­tion­al stud­ies, al­though their cur­rent tri­al in­cludes treat­ment-naive arms.

So­cial im­age: Frank Lee, For­ma CEO

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