Abstract 746P
Background
In the primary analysis of the MIRASOL trial, MIRV demonstrated superior progression-free survival (PFS), objective response rate, and overall survival (OS), over ICC in patients (pts) with high-grade serous PROC (Moore K et al. N Engl J Med 2023;389:2162-74) with a median follow-up time of 11.2 months. Here, we report updated nonanalytical results based on a median follow-up of 16.7 months.
Methods
453 PROC pts with high FRα expression (VENTANA FOLR1 [FOLR1-2.1] RxDx Assay) with 1-3 prior therapies were randomized 1:1 to MIRV 6 mg/kg, adjusted ideal body weight, Day 1 of a 21-day cycle or ICC: paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo). The primary efficacy endpoint was PFS by an investigator, with key secondary endpoints ORR, OS, and patient-reported outcomes in hierarchical order; other endpoints included safety, tolerability, and duration of response.
Results
With an extended data cutoff of October 27, 2023, the mPFS was 5.6 months (95% CI 4.3, 6.0) for MIRV vs 4.0 months (95% CI 2.9, 4.5) for ICC with a hazard ratio (HR) of 0.65 (95% CI 0.53, 0.80). The mOS was 16.5 months (95% CI 14.4, 19.9) for MIRV and 13.3 months (95% CI 11.4, 15.4) for ICC with a HR of 0.67 (95% CI 0.53, 0.85). The adverse event (AE) profile of MIRV was consistent with prior reports and included: blurred vision (MIRV 43% vs ICC 2%; grade 3+ 8% vs 0), keratopathy (MIRV 33% vs. ICC 0; grade 3+ 9% vs 0), abdominal pain (MIRV 31% vs ICC 15%; grade 3+ 3% vs 1%), fatigue (MIRV 30% vs ICC 25%; grade 3+ 2% vs 5%), diarrhea (MIRV 29% vs ICC 17%; grade 3+ 1% vs <1%). Compared with ICC, MIRV was associated with lower rates of grade 3+ treatment-emergent AEs (43% vs. 54%), serious AEs (25% vs. 33%), and discontinuations due to TEAEs (10% vs. 16%). 5% of pts on the MIRV arm remained on study drug vs <1% on the IC arm.
Conclusions
With a median follow-up of 16.7 months, MIRV demonstrated improved efficacy vs ICC in pts with PROC. The efficacy data, along with the well-characterized safety profile, supports MIRV as the standard of care for pts with FRα positive PROC. Clinical Trial Information: NCT04209855.
Clinical trial identification
NCT04209855.
Editorial acknowledgement
Legal entity responsible for the study
ImmunoGen, Inc.
Funding
ImmunoGen, Inc.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
682TiP - A phase I, first-in-human study of DS-1471 in patients with advanced/metastatic solid tumors
Presenter: Shigehiro Koganemaru
Session: Poster session 01
683TiP - A phase I study of PARP inhibitor (niraparib) plus HSP90 inhibitor (pimitespib) in solid tumors: The NiraPim (EPOC2102) study
Presenter: Hiromichi Nakajima
Session: Poster session 01
684TiP - A phase I, open-label, multicenter, dose escalation and expansion study of HM97662 (EZH1/2 dual inhibitor) as a single agent in patients with advanced or metastatic solid tumors
Presenter: Bhumsuk Keam
Session: Poster session 01
685TiP - A phase I, multicenter trial (“KinLET”) of [177Lu]Lu-edotreotide for treatment of somatostatin receptor positive solid tumors or lymphoma, in patients two to less than 18 years of age
Presenter: Maria Cristina Mata Fernandez
Session: Poster session 01
687TiP - A phase I, first in human study of TORL-4-500 in patients with advanced cancer
Presenter: Jonathan Goldman
Session: Poster session 01
688TiP - Phase I dose escalation trial to evaluate safety and preliminary efficacy of ACR246, an innovative 5T4- antibody drug conjugate (ADC), in patients (pts) with advanced solid tumors
Presenter: Xihui Hu
Session: Poster session 01
689TiP - A phase I/IIa trial of Aurora-A inhibitor (JAB-2485) in adult patients with advanced solid tumors
Presenter: Vaia Florou
Session: Poster session 01
690TiP - HERTHENA-PanTumor01: A global phase II trial of HER3-DXd in metastatic solid tumors
Presenter: Thomas Powles
Session: Poster session 01
691TiP - PYNNACLE phase II trial of rezatapopt (PC14586) in solid tumors with a TP53 Y220C mutation
Presenter: Alison Schram
Session: Poster session 01