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OP007/#276 Phase I study of mirvetuximab soravtansine (MIRV) and rucaparib for recurrent endometrial, ovarian, fallopian tube or primary peritoneal cancer
  1. F Backes1,
  2. J Fowler1,
  3. L Copeland1,
  4. L Wei2,
  5. D O’Malley1,
  6. D Cohn1,
  7. C Cosgrove1,
  8. J Hays3 and
  9. K Bixel1
  1. 1The Ohio State University, Obstetrics and Gynecology; Division of Gynecologic Oncology, Columbus, USA
  2. 2The Ohio State University, Center For Biostatistics, Columbus, USA
  3. 3The Ohio State University, Division of Medical Oncology, Columbus, USA


Objectives To estimate the maximally tolerated dose (MTD) and toxicities associated with MIRV and rucaparib.

Methods Patients had to be folate receptor α (FRα) positive by IHC (≥25% of tumor staining at ≥2+ intensity). Using a 3+3 design patients received MIRV (4–6 mg/kg IV every 3 weeks) and rucaparib PO BID (400–600 mg) depending on the dose level.

Results >100 patients were screened for FRα expression; 21 have been enrolle, 16 with ovarian and 5 with endometrial cancer. Median age was 64.5, with 3 (range 1–9) prior lines of treatment. 6 patients completed DL2 (5/500), however, 2 DLTs (grade 3 fatigue), let us to establish the RP2D at DL1 (MIRV 5 mg/kg IV every 3 weeks and rucaparib 400 mg PO BID). Treatment related toxicities (all grades) occurring in ≥25% of patients included fatigue (73%), nausea (67%), blurred vision (60%), anemia (47%), anorexia (47%), mucositis (40%), ALT/AST elevated (40%), dry eyes (33%), vomiting (27%), thrombocytopenia (27%), weight loss (27%), leukopenia (27%), dysgeusia (27%). Grade ≥3 toxicities were fatigue (20%), pneumonitis (13%), anemia (13%), diarrhea (7%), cataract (7%), lymphopenia (7%), thrombocytopenia (7%), weight loss (7%), hypokalemia (7%). Sixteen patients are currently evaluable for response; 6 (37.5%) with PR, 8 (50%) SD, 2 (12.5%) PD; ORR 33% (4/12) in ovarian cancer and 50% (2/4) in endometrial cancer. Median PFS is 6.3 months with 95%CI (0.7, 13.8) months.

Conclusions Combination rucaparib and MIRV was tolerable with mostly manageable side effects and encouraging activity in this heavily pretreated population (including prior PARPi) of both endometrial and ovarian cancer.

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