Piccolo points the way to earlier Elahere use
AbbVie has confirmed ImmunoGen’s earlier claim that Elahere’s Piccolo study is positive. The uncontrolled trial tests the folate receptor alpha (FRα) targeting ADC in platinum-sensitive ovarian cancer, thus looking at the maintenance setting rather than the platinum-refractory use in which the drug is already approved. It’s not clear whether AbbVie will pursue accelerated approval in this earlier use, but the fact that Gloriosa, a potentially confirmatory phase 3 study in platinum-sensitive disease, is already under way suggests that it might. Last November, just before AbbVie announced its $10.1bn takeover of ImmunoGen, the latter company said an early cut of Piccolo suggested a positive outcome; no numbers were revealed, but Piccolo was designed to rule out an ORR of 28% or less, and ImmunoGen said it expected more mature data to show ORR of at least 48%. In the event AbbVie yesterday said the number came in at 51.9%, with median duration of response of 8.25 months. Elahere’s label limits the drug to high FRα-expressing patients, and Piccolo also set this as an inclusion criterion. The precise cutoff is important in gauging the ability of follow-on anti-FRα ADCs to challengers Elahere in ovarian cancer.
Selected Elahere trials in FRα-high ovarian cancer
| Study | Setting | Data | Note |
|---|---|---|---|
| Platinum-resistant | |||
| Soraya | ≤4L (post-Avastin), uncontrolled | 32% cORR by investigator assessment | Backed accelerated approval, Nov 2022 |
| Mirasol | ≤4L, vs chemo | PFS HR=0.65 (p<0.0001), OS HR=0.67 (p=0.0046) | Backed full approval, Mar 2024 |
| Maintenance | |||
| Piccolo | 3L (post platinum, but still platinum-sensitive), uncontrolled | 52% ORR by investigator assessment | Study aimed to rule out ≤28% ORR |
| Gloriosa | 2L (post platinum, but still platinum-sensitive), Avastin combo, vs Avastin | PFS is primary, Mar 2027 completion | Potential confirmatory trial, started Dec 2022 |
Source: OncologyPipeline.
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