Agios lines up sol­id PhI­II da­ta to back Tib­sovo's use in bile duct can­cer — ahead of planned sN­DA

BARCELONA — A lit­tle more than a year af­ter se­cur­ing the first FDA ap­proval for ivosi­denib — now on the mar­ket as Tib­so­vo for acute myeloid leukemia — Agios has lined up an­oth­er slate of da­ta in a type of sol­id tu­mor to take to reg­u­la­tors by the end of the year.

The key take­away: For a ge­net­i­cal­ly-de­fined group of pa­tients with cholan­gio­car­ci­no­ma, or bile duct can­cer, who have gone through one to two rounds of chemother­a­py, ivosi­denib pro­longed pro­gres­sion-free sur­vival, with a 6-month PFS of 32% and a 12-month rate of 22% while all pa­tients on the place­bo arm had pro­gressed by 6 months.

In terms of num­bers, the me­di­an PFS on ivosenibd was 2.7 months com­pared to 1.4 months on place­bo — a haz­ard ra­tio of 0.37 (p<0.001) that Agios says is re­mark­able for this ag­gres­sive form of can­cer.

“I think that when you look at the curve, it re­al­ly tells the sto­ry as op­posed to fo­cus­ing on the me­di­an,” said Su­san Pandya, VP of clin­i­cal de­vel­op­ment. Be­sides, “our over­all sense of how chemother­a­py per­forms in this set­ting is that OS out­come is around 6 months in pa­tients who have sec­ond-line chemother­a­py. So to see a pro­gres­sion-free sur­vival rate of 32% at 6 months is re­al­ly com­pelling.”

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