Gynecologic oncology · 2025
Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in patients with platinum-resistant ovarian cancer.
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Matulonis Ursula A, Vergote Ignace, Moore Kathleen N, Martin Lainie P, Castro Cesar M, Gilbert Lucy, Xia Yu, Method Michael, Stec James, Birrer Michael J, O'Malley David M
Аннотация
OBJECTIVE: Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients with platinum-resistant ovarian cancer (PROC).
METHODS: Participants with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease relapsed ≤6 months from last platinum-based treatment received MIRV (6 mg/kg adjusted ideal body weight) and pembrolizumab (200 mg) intravenously once every 3 weeks. Tumor FRα expression thresholds were ≥25 % (dose escalation cohort) and ≥50 % (dose expansion cohort) of cells with ≥2+ membrane staining intensity. The primary efficacy endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.
RESULTS: Fifty-six participants received the doublet. Median age was 62 years (range, 40-78). Twenty percent of participants had 3 prior lines of systemic treatment, 43 % had ≥4 prior lines, 43 % had prior bevacizumab exposure, and 41 % had prior PARP inhibitor exposure. Among 55 response-evaluable participants, ORR was 31 % (95 % CI, 19-45), median DOR was 8.0 months (95 % CI, 4.2-NR), and median PFS was 4.2 months (95 % CI, 2.8-5.6). Efficacy persisted in patients with multiple prior lines of treatment. Treatment-emergent adverse events were consistent with the profiles of each agent; the most common were diarrhea (all grades, 57 %; grade 3, 4 %), nausea (55 %; 5 %), and fatigue (50 %; 2 %). Treatment-emergent pneumonitis occurred in 25 % of participants, with grade ≥3 events occurring in 2 (4 %) participants.
CONCLUSIONS: MIRV plus pembrolizumab demonstrated anti-cancer efficacy and a tolerable safety profile in heavily pretreated patients with PROC. However, the efficacy benefit may be mainly attributable to MIRV alone.
METHODS: Participants with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease relapsed ≤6 months from last platinum-based treatment received MIRV (6 mg/kg adjusted ideal body weight) and pembrolizumab (200 mg) intravenously once every 3 weeks. Tumor FRα expression thresholds were ≥25 % (dose escalation cohort) and ≥50 % (dose expansion cohort) of cells with ≥2+ membrane staining intensity. The primary efficacy endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.
RESULTS: Fifty-six participants received the doublet. Median age was 62 years (range, 40-78). Twenty percent of participants had 3 prior lines of systemic treatment, 43 % had ≥4 prior lines, 43 % had prior bevacizumab exposure, and 41 % had prior PARP inhibitor exposure. Among 55 response-evaluable participants, ORR was 31 % (95 % CI, 19-45), median DOR was 8.0 months (95 % CI, 4.2-NR), and median PFS was 4.2 months (95 % CI, 2.8-5.6). Efficacy persisted in patients with multiple prior lines of treatment. Treatment-emergent adverse events were consistent with the profiles of each agent; the most common were diarrhea (all grades, 57 %; grade 3, 4 %), nausea (55 %; 5 %), and fatigue (50 %; 2 %). Treatment-emergent pneumonitis occurred in 25 % of participants, with grade ≥3 events occurring in 2 (4 %) participants.
CONCLUSIONS: MIRV plus pembrolizumab demonstrated anti-cancer efficacy and a tolerable safety profile in heavily pretreated patients with PROC. However, the efficacy benefit may be mainly attributable to MIRV alone.
Предметные рубрики MeSH
AdultAgedFemaleHumansMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialDrug Resistance, NeoplasmFallopian Tube NeoplasmsFolate Receptor 1ImmunoconjugatesMaytansineNeoplasm Recurrence, LocalOvarian NeoplasmsProgression-Free Survival