# Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I

Source: https://onco.cc/key-papers/paper-mirvetuximab-soravtansine-ovarian-ann-oncol-2021/  
OnCo record `paper-mirvetuximab-soravtansine-ovarian-ann-oncol-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Phase 2 or 3 results paper on Mirvetuximab soravtansine in Ovarian cancer, in Annals of Oncology (2021), one of the most cited Europe PMC records with Mirvetuximab soravtansine in its title.

## Summary

Background: Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. The randomized, open-label, phase III study FORWARD I compared MIRV and investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian cancer (EOC).

Patients and methods: Eligible patients with 1-3 prior lines of therapy and whose tumors were positive for FRα expression were randomly assigned, in a 2: 1 ratio, to receive MIRV (6 mg/kg, adjusted ideal body weight) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary endpoint was progression-free survival [PFS, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, blinded independent central review] in the intention-to-treat (ITT) population and in the prespecified FRα high population.

Results: A total of 366 patients were randomized; 243 received MIRV and 109 received chemotherapy. The primary endpoint, PFS, did not reach statistical significance in either the ITT [hazard ratio (HR), 0.98, P = 0.897] or the FRα high population (HR, 0.69, P = 0.049). Superior outcomes for MIRV over chemotherapy were observed in all secondary endpoints in the FRα high population including improved objective response rate (24% versus 10%), CA-125 responses (53% versus 25%), and patient-reported outcomes (27% versus 13%). Fewer treatment-related grade 3 or higher adverse events (25.1% versus 44.0%), and fewer events leading to dose reduction (19.8% versus 30.3%) and treatment discontinuation (4.5% versus 8.3%) were seen with MIRV compared with chemotherapy.

Conclusions: In patients with platinum-resistant EOC, MIRV did not result in a significant improvement in PFS compared with chemotherapy. Secondary endpoints consistently favored MIRV, particularly in patients with high FRα expression. MIRV showed a differentiated and more manageable safety profile than chemotherapy.

Indexed on Europe PMC as PubMed record 33667670 (DOI 10.1016/j.annonc.2021.02.017). Its title names Mirvetuximab soravtansine and its text names Ovarian cancer; PubMed types it as a clinical trial report (Clinical Trial, Phase III, Research Support, Non-U.S. Gov't, Randomized Controlled Trial). It was matched automatically to the idea "Sequence folate-receptor ADCs by payload class" and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Annals of Oncology
- Year: 2021
- DOI: 10.1016/j.annonc.2021.02.017
- Authors: Moore KN, Oza AM, Colombo N, et al.
- What it means: One of the most cited trial reports Europe PMC returns for Mirvetuximab soravtansine in Ovarian cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched by Mirvetuximab soravtansine in the title and Ovarian cancer in the title or abstract of the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a phase 2 or 3 report by the record's publication type or its own wording, not by reading the paper.

## Sources

- Ann Oncol 2021: https://doi.org/10.1016/j.annonc.2021.02.017
- PubMed: https://pubmed.ncbi.nlm.nih.gov/33667670/
- Europe PMC: https://europepmc.org/article/MED/33667670

## Connected records

- journals: [Annals of Oncology](https://onco.cc/journals/annals-of-oncology/)
- ideas: [Sequence folate-receptor ADCs by payload class](https://onco.cc/ideas/idea-fra-adc-sequencing-ovarian/)

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