Nuvation Bio has backed off from its plans to directly compare its brain cancer drug to Servier's Voranigo, instead opting to focus on patients who aren’t covered by the approved competitor.
Nuvation’s plans for its brain-penetrant mIDH1 inhibitor, called safusidenib, had involved a head-to-head study against Voranigo (vorasidenib) to back up an approval application for patients with non-enhancing grade 2 IDH1-mutant glioma. Last year, Voranigo became the first systemic therapy to get approved for low-grade glioma with a susceptible IDH1 or IDH2 mutation.
After discussions with the FDA, Nuvation disclosed that it has “decided not to pursue a head-to-head randomized study of safusidenib against vorasidenib to support approval in non-enhancing grade 2 IDH1-mutant glioma.”
Instead, the biopharma will focus this strand of its safusidenib program on high-risk subgroups of low-grade IDH1-mutant glioma. Voranigo is not approved for these patients, Nuvation noted in its third-quarter earnings release.
Gliomas are the most common type of brain cancer diagnosed in adults, with nearly 2,400 cases of IDH1-mutant gliomas diagnosed in the U.S. each year, according to Nuvation.
Last month, Nuvation launched a global study of safusidenib as a maintenance treatment for high-grade IDH1-mutant glioma. Having taken on board additional feedback from the FDA, the company also said it now plans to enroll 300 patients in the phase 3 trial to support an approval application in this indication.
Announcing the launch of the trial in October, Nuvation CEO David Hung, M.D., pointed out that “no targeted therapies have been approved to delay recurrence or progression in these patients, who are dealing with an aggressive disease that inevitably returns.”
The company has previously pointed to safusidenib’s antitumor activity and high blood-brain barrier penetration as demonstrated in a phase 1 study.
Nuvation’s only approved product, the non-small cell lung drug Ibtrozi, began shipping to U.S. patients in June and brought in $7.7 million in sales in the third quarter.
The biopharma was down around 5.5% in premarket trading.