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Immunomedics Will Present New Trodelvy Data In Non-Breast Cancer Indications At ASCO

Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that its recently

Benzinga · 05/13/2020 21:28

Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that its recently FDA-approved ADC, Trodelvy, showed clinical activity in cisplatin-ineligible patients with metastatic urothelial cancer (mUC) and in patients with previously-treated metastatic endometrial cancer (mEC).

“These early-stage study data highlight the potential broad utility of Trodelvy and strengthen our premise of targeting Trop-2 for the delivery of SN-38,” said Dr. Loretta M. Itri, Chief Medical Officer. “Trodelvy is now being developed for a broad spectrum of epithelial cancers, either independently or in close collaboration with key opinion leaders and corporate partners.”

Trodelvy in cisplatin-ineligible mUC

In TROPHY U-01 cohort 2, at a median follow-up of 6.8 months, Trodelvy produced an objective response rate (ORR) of 29 percent (95% confidence interval [CI], 12–54) in 21 patients with mUC who were platinum ineligible and had progressed after prior checkpoint inhibitor (CPI) therapy, which is consistent with the 29 percent observed in the interim results from TROPHY U-01 cohort 1 of 35 mUC patients who were previously exposed to platinum-based and CPI therapies. While median duration of response (DOR) was not reached at the time of data cutoff, median progression-free survival (PFS) was 5.5 months (95% CI, 1.7–7.3) and median overall survival (OS) was 11.1 months (95% CI, 4.9–not available). Top-line data from the full cohort 1 of 100 patients are expected to be available in the second half of 2020.

Trodelvy in previously-treated mEC

Preclinical studies have shown Trodelvy to have activity against chemotherapy-resistant EC and significant bystander effect against EC with heterogenous Trop-2 expression.1 To evaluate this activity clinically, mEC patients who progressed after more than one prior systemic therapy were enrolled into a Phase 1/2 single-arm basket study.

At a median follow-up of 12.7 months, treatment with Trodelvy resulted in an ORR of 22 percent (95% CI, 6.4–47.6) in 18 mEC patients that had a median 3.5 (range 2–6) prior lines of therapy. All patients had previously received platinum therapies. DOR of responders ranged from 9.1 to 26.6 months, with 2 of 4 responders having a duration of 18 months or longer. Median PFS and OS was 3.2 months (95% CI, 1.9–9.4) and 11.9 months (95% CI, 4.7–not available), respectively. Clinical benefit rate was 44 percent (95% CI, 21.5–69.2).

The safety profile of Trodelvy in these two cohorts were consistent with prior reports in other cancer indications, including key grade 3 or higher treatment-related adverse events of neutropenia, diarrhea, and febrile neutropenia. No events of interstitial lung disease, ocular toxicities, or grade 2 or higher neuropathy were reported. There were no treatment-related deaths.

Details of the poster presentations at ASCO20 Virtual Scientific Program:

Date: Friday, May 29, 2020
Time: 8:00 a.m. – 11:00 a.m. Eastern Time

  1. Early results of TROPHY U-01 cohort 2: sacituzumab govitecan (SG) in platinum-ineligible patients (pts) with metastatic urothelial cancer (mUC) who progressed after prior checkpoint inhibitor (CPI) therapy (Petrylak, et al.)
    Session Title: Genitourinary Cancer—Kidney and Bladder
    Abstract #: 5027
    Poster #: 96
  2. Sacituzumab govitecan (SG) in patients (pts) with previously treated metastatic endometrial cancer (mEC): results from a phase 1/2 study (Santin, et al.)
    Session Title: Gynecologic Cancer
    Abstract #: 6081
    Poster #: 252
    1. TROPiCS-03: A phase 2 open-label study of sacituzumab govitecan (SG) in patients with metastatic solid tumors (Saxena, et al.)
      Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
      Abstract #: TPS3648
      Poster #: 378