JP Morgan 2023 – Novartis and Gilead's interim halt hopes wane

As 2023 got under way investors in Novartis and Gilead might have been looking for pleasant surprises from interim analyses of two key studies. Such hopes have been dashed, according to updates slipped out at the JP Morgan healthcare conference this week. Novartis’s Kisqali is trying to break into adjuvant breast cancer, where Lilly’s rival Verzenio is approved but where Pfizer’s Ibrance failed in the Pallas trial. But Kisqali’s Natalee study is now continuing to a possible second interim analysis by the mid-year, having not been halted for efficacy at the first, which came and went at 70% of disease progressions. Meanwhile, the Enhance trial of Gilead’s anti-CD47 MAb magrolimab in first-line high-risk myelodysplastic syndromes had an expected first interim analysis in the current quarter, but this too has passed without triggering a halt for efficacy. The CD47 mechanism has disappointed, and Enhance's focus now turns to a second interim analysis in the second half of the year.

Project Kisqali Magrolimab
Company Novartis Gilead (ex Forty Seven)
Trial Natalee Enhance
Setting Adjuvant pre & postmenopausal ER+/Her2- breast cancer;
(approved for 1st-line metastatic ER+/Her2- breast cancer)
1st-line, high-risk MDS;
(also in pivotal trials for 1st-line TP53m AML (Enhance-2) & 1st-line unfit AML (Enhance-3), as well as other haem & solid cancers)
Interim analyses 1st at 70% of iDFS events (YE 2022, not halted) 1st at unspecified threshold (H1 2023, not halted)

Continues to 2nd interim analysis (H1 2023) at 85% of iDFS events;
final analysis (H2 2023) at 500 iDFS events 

Continues to 2nd interim analysis (H2 2023), with focus on OS (currently a co-primary endpoint along with CR rate);
(NB had been on clinical hold in 2022)
Source: & JP Morgan presentations.

After this story was published Novartis clarified that the second interim analysis of Natalee had yet to take place.

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