On May 13, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate (Press release, ImmunoGen, MAY 13, 2020, View Source [SID1234557939]). These findings will be highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program on May 29, 2020. Three "trial in progress" posters will also be presented during the meeting.

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"With the benefit of the clinical profile demonstrated by mirvetuximab monotherapy, we have pursued a development strategy to establish mirvetuximab as the agent of choice in combination regimens to treat expanded populations of patients with recurrent ovarian cancer. To this end, we are encouraged by the compelling anti-tumor activity and favorable tolerability observed with the combination of mirvetuximab plus bevacizumab in patients for whom a non-platinum based regimen is appropriate," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These findings show greater depth and duration of tumor reduction in women whose tumors express high levels of FRα, regardless of platinum status, reinforcing the potential of this doublet in these patients. As these data mature, we look forward to further evaluating this combination in the recurrent ovarian cancer setting."

INITIAL DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB
This cohort enrolled 60 patients with FRα-positive recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate, with a median age of 60 years and a median number of 2 prior lines of therapy (range 1-4). The combination of mirvetuximab soravtansine with bevacizumab in this cohort demonstrates encouraging anti-tumor activity with a favorable tolerability profile, particularly among the subset of patients with high levels of FRα expression.

Key findings include:

In the overall patient population, objective responses were seen in 26 patients and the confirmed overall response rate (ORR) was 43% (95% CI, 31, 57).
In patients with high FRα expression (n=33), the confirmed ORR was 61% (95% CI, 42, 77), with an ORR of at least 50% in each of the platinum-resistant and platinum-sensitive subgroups.
With many patients remaining on study, the duration of response and progression free survival data are immature.
The adverse events (AEs) observed with the doublet were as expected based on the side effect profiles of each agent. The most common treatment-related low grade AEs were diarrhea, blurred vision, nausea, and fatigue; grade 3+ AEs were infrequent, with the most common being hypertension and neutropenia.
"With the increasing need for non-platinum regimens in recurrent ovarian cancer, we are excited to further advance mirvetuximab in combination with bevacizumab, building on the prior data for this combination in women with platinum resistant disease," stated Lucy Gilbert, MD, Professor, and Director of the Gynecologic Oncology Division at McGill University Health Center in Montreal, Canada. "These initial data demonstrate meaningful clinical benefit in women with recurrent disease, regardless of platinum status, and I look forward to reporting longer-term follow up and further evaluating the doublet in this expanded patient population."

ORAL PRESENTATION SESSION

Title: "Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer"
Day/Time: Friday, May 29 at 8:00 AM ET
Lead Author: Lucy Gilbert, MD, McGill University Health Center, Montreal, Canada
Abstract: 6004
TRIAL IN PROGRESS POSTERS
The following posters will be available on Friday, May 29 at 8:00 AM ET in the ASCO (Free ASCO Whitepaper) Meeting Library:

Title: "MIRASOL (GOG 3045/ENGOT OV-55): A Randomized, Open-label, Phase 3 study of Mirvetuximab Soravtansine versus Investigator’s Choice of Chemotherapy in Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor Alpha (FRα) Expression"
Lead Author: Kathleen Moore, MD, University of Oklahoma Health Sciences Center
Abstract: TPS6103 (Poster 274)
Title: "A Phase 1/2 Study of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, and Other CD123-Positive Hematologic Malignancies"
Lead Author: Naval Daver, MD, MD Anderson Cancer Center
Abstract: TPS7563 (Poster 336)
Title: "A Phase 1b/2 Study of the CD123-Targeting Antibody-Drug Conjugate IMGN632 as Monotherapy or in Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia"
Lead Author: Naval Daver, MD, MD Anderson Cancer Center
Abstract: TPS7564 (Poster 337)
Additional information can be found at www.asco.org.

ABOUT FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin, or Keytruda (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.