Mirvetuximab Soravtansine Shows Survival Benefit in Ovarian Cancer Subtype

Article

Based on findings from the phase 3 MIRASOL trial, investigators plan to submit a supplemental biologics license application for mirvetuximab soravtansine in folate receptor α–positive platinum-resistant ovarian cancer.

Treatment with mirvetuximab soravtansine-gynx (Elahere) yielded improved outcomes compared with chemotherapy in patients with folate receptor α (FRα)–positive platinum-resistant ovarian cancer who have received prior therapy, according to a press release on topline data from the phase 3 MIRASOL (GOG 3045/ENGOT OV-55) trial (NCT04209855).1

The FDA previously granted accelerated approval to mirvetuximab soravtansine in FRα-positive platinum-resistant ovarian cancer in November 2022.

The FDA previously granted accelerated approval to mirvetuximab soravtansine in FRα-positive platinum-resistant ovarian cancer in November 2022.

The median overall survival (OS) was 16.46 months with mirvetuximab vs 12.75 months with chemotherapy of investigator’s choice (Hazard ratio [HR], 0.67; P = .0046). Additionally, the median progression-free survival (PFS) was 5.62 months vs 3.98 months in each respective arm (HR, 0.65; P <.0001).

The investigator-assessed objective response rate (ORR) was 42.3% with 12 patients achieving complete responses (CRs) with mirvetuximab vs 15.9% with no CRs with investigator’s choice chemotherapy. The PFS and ORR by blinded independent central review were consistent with the investigator assessments.

Based on data from the MIRASOL trial, investigators will submit a supplemental biologics license application to the FDA seeking conversion to a regular approval for mirvetuximab in FRα-positive platinum-resistant ovarian cancer following the agency’s decision to grant accelerated approval to the agent in November 2022.2 Investigators also plan to submit a marketing authorization application for mirvetuximab’s approval in Europe.

“We believe these data will provide the foundation for pursuing a marketing authorization in Europe and elsewhere, and seeking full approval in the U.S., support our goal of delivering [mirvetuximab] to FRα-positive patients worldwide, and reinforce our conviction in our clinical development program to move this therapy into broader populations, including platinum-sensitive disease,” Mark Enyedy, president and chief executive officer of ImmunoGen, said in the press release.

Investigators of the randomized, open-label phase 3 MIRASOL trial evaluated mirvetuximab compared with chemotherapy in the treatment of patients with platinum-resistant FRα-positive ovarian cancer. In the experimental arm, patients received 6 mg/kg adjusted ideal body weight of mirvetuximab every 3 weeks. In the comparator arm, patients received either 80 mg/m2 of paclitaxel once per week, 40 mg/m2 of pegylated liposomal doxorubicin every 4 weeks, or 4 mg/m2 of topotecan on days 1, 8, and 15 every 4 weeks or 1.25 mg/m2 on days 1 to 5 every 3 weeks.

The primary end point was PFS by investigator assessment. Secondary end points included ORR, OS, duration of response, and safety and tolerability.

Patients 18 years and older who had a confirmed diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with platinum-resistant disease were eligible for enrollment on the trial. Additional inclusion criteria included having tumors positive for FRα expression, progressive disease on or after the most recent line of therapy, and at least 1 measurable lesion per RECIST v1.1 criteria.

Investigators of the MIRASOL trial enrolled 453 patients. Overall, 14% of patients received 1 prior line of therapy, 39% received 2 prior lines, and 47% received 3 prior lines. Additionally, 62% of patients previously received treatment with bevacizumab (Avastin), and 55% received prior treatment with a PARP inhibitor.

There were no new safety signals identified in the MIRASOL trial. Grade 3 or higher treatment-emergent adverse effects (TEAEs) occurred in 42% of patients in the mirvetuximab arm vs 54% of those in the chemotherapy arm. Additionally, serious AEs occurred in 24% vs 33% of patients in each respective arm. TEAEs leading to treatment discontinuation occurred in 9% vs 16% of patients in each respective arm.

References

  1. ELAHERE® demonstrates overall survival benefit in the phase 3 MIRASOL trial in patients with FRα-positive platinum-resistant ovarian cancer. News release. ImmunoGen. May 3, 2023. Accessed May 3, 2023. bit.ly/42pdZ6h
  2. ImmunoGen announces FDA accelerated approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. News release. ImmunoGen. November 14, 2022. Accessed May 3, 2023. https://bwnews.pr/3AayMyH
Related Videos
Brian Slomovitz, MD, MS, FACOG discusses the use of new antibody drug conjugates for treating patients with various gynecologic cancers.
Developing novel regimens may continue to improve survival outcomes of patients with advanced cervical cancer following the FDA approval of pembrolizumab and chemoradiation, says Jyoti S. Mayadev, MD.
Treatment with pembrolizumab plus chemoradiation appears to be well tolerated with no detriment to quality of life among those with advanced cervical cancer.
Jyoti S. Mayadev, MD, says that pembrolizumab in combination with chemoradiation will be seamlessly incorporated into her institution’s treatment of those with FIGO 2014 stage III to IVA cervical cancer following the regimen’s FDA approval.
Domenica Lorusso, MD, PhD, says that paying attention to the quality of chemoradiotherapy is imperative to feeling confident about the potential addition of pembrolizumab for locally advanced cervical cancer.
Guidelines from the Society of Gynecologic Oncology may help with managing the ongoing chemotherapy shortage in the treatment of patients with gynecologic cancers, according to Brian Slomovitz, MD, MS, FACOG.
Interim data reveal favorable responses in patients with low-grade serous ovarian cancer treated with avutometinib plus defactinib, according to Susana N. Banerjee, MD.
Brian Slomovitz, MD, MS, FACOG, notes that sometimes there is a need to substitute cisplatin for carboplatin, and vice versa, to best manage gynecologic cancers during the chemotherapy shortage.
Findings from the phase 3 MIRASOL trial support mirvetuximab soravtansine as a standard treatment option for platinum-resistant ovarian cancer, according to Ritu Salani, MD.
Trastuzumab deruxtecan appears to elicit ‘impressive’ responses among patients with HER2-positive gynecologic cancers regardless of immunohistochemistry in the phase 2 DESTINY-PanTumor02 trial.
Related Content
Combining rintatolimod with pembrolizumab may confer a synergistic effect in patients with recurrent ovarian cancer.

Rintatolimod Combo Yields Clinical Benefit in Recurrent Ovarian Cancer

April 11th 2024
Article

Combining rintatolimod with pembrolizumab may confer a synergistic effect in patients with recurrent ovarian cancer.

The FDA approval of pembrolizumab plus chemoradiation benefits patients with stage III to IVA cervical cancer based on findings from the KEYNOTE-A18 trial, according to Jyoti S. Mayadev, MD.

Jyoti S. Mayadev, MD, on Pembrolizumab/CRT FDA Approval in Cervical Cancer

January 22nd 2024
Podcast

The FDA approval of pembrolizumab plus chemoradiation benefits patients with stage III to IVA cervical cancer based on findings from the KEYNOTE-A18 trial, according to Jyoti S. Mayadev, MD.

Even when adjusting for prior taxane responses in patients with ovarian cancer, ixabepilone/bevacizumab appears to yield survival benefits in a phase 2 trial.

Ixabepilone Combo Improves PFS/OS in Platinum-Resistant Ovarian Cancer

March 28th 2024
Article

Even when adjusting for prior taxane responses in patients with ovarian cancer, ixabepilone/bevacizumab appears to yield survival benefits in a phase 2 trial.

Pharmaceutical, gynecologic oncology, and physician perspectives shed light on potentially mitigating the ongoing carboplatin and cisplatin shortages’ effects on cancer care in the United States.

Navigating the Impact of Chemotherapy Shortages on Cancer Care and Finances

September 18th 2023
Podcast

Pharmaceutical, gynecologic oncology, and physician perspectives shed light on potentially mitigating the ongoing carboplatin and cisplatin shortages’ effects on cancer care in the United States.

Several patients with TP53 Y220C–mutated ovarian cancer experience tumor shrinkage following treatment with rezatapopt in the phase 1/2 PYNNACLE study.

Rezatapopt Yields Early Responses, Safety in Advanced Ovarian Cancer

March 24th 2024
Article

Several patients with TP53 Y220C–mutated ovarian cancer experience tumor shrinkage following treatment with rezatapopt in the phase 1/2 PYNNACLE study.

Data from the phase 3 MIRASOL trial support the full FDA approval of mirvetuximab soravtansine for those with folate receptor alpha–positive platinum-resistant ovarian cancer.

FDA Approves Mirvetuximab Soravtansine in FRα+ Ovarian Cancer

March 22nd 2024
Article

Data from the phase 3 MIRASOL trial support the full FDA approval of mirvetuximab soravtansine for those with folate receptor alpha–positive platinum-resistant ovarian cancer.