Immunomedics (IMMU) Phase 3 ASCENT Study of TRODELVY in Previously-Treated Patients with mTNBC Met Primary Endpoint

Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the confirmatory Phase 3 ASCENT study of Trodelvy (sacituzumab govitecan-hziy) met its primary endpoint of progression-free survival (PFS), as well as key secondary endpoints in brain metastasis negative patients with mTNBC who have previously received at least two prior therapies for metastatic disease.

“The results of the global Phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC. Based on these data, sacituzumab govitecan has set a new benchmark in scientific and clinical innovation for patients with mTNBC by offering a novel alternative to the common drugs currently in clinical practice. Importantly, the ASCENT topline data also validate the manageable safety profile of sacituzumab govitecan, rendering it a good partner candidate for combination with other therapies, including immunotherapy,” stated the study principal investigator, Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Mass General Cancer Center and Assistant Professor of Medicine at Harvard Medical School.

In the ASCENT study, Trodelvy demonstrated a statistically significant improvement in the primary endpoint of PFS compared to chemotherapy, with a hazard ratio of 0.41 (95% confidence interval (CI), 0.32-0.52). The median PFS for patients treated with Trodelvy was 5.6 months (95% CI, 4.3-6.3), compared to 1.7 months (95% CI, 1.5-2.6) for chemotherapy (p<0.0001). Trodelvy also met key secondary endpoints of the study, including overall survival and objective response rate. The safety profile of Trodelvy observed in the ASCENT study remained consistent with the U.S. Food and Drug Administration (FDA)-approved label, with neutropenia and diarrhea as the most common Grade 3 or 4 adverse events and no new safety signals were observed. Full results will be presented at an upcoming medical conference.

“Given the poor prognosis associated with mTNBC, we are excited that Trodelvy demonstrated improved clinical outcomes for these patients,” said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. “We are grateful to all the patients, their families and healthcare providers, as well as our colleagues at Immunomedics, who participated in the ASCENT study and overcame many obstacles, including the COVID-19 pandemic, to complete the collection and analyses of these important data. We look forward to presenting full results at an upcoming medical conference, as well as sharing them with the FDA in support of the full approval of Trodelvy in this difficult-to-treat cancer.”

Trodelvy was recently approved by the FDA as a third-line treatment for adult patients with mTNBC under the agency’s Accelerated Approval Program based on the objective response rate and duration of response observed in a single-arm, multicenter Phase 2 study. The Phase 3 confirmatory ASCENT study was designed under an FDA Special Protocol Assessment (SPA) to validate the promising safety and efficacy activity of Trodelvy that supported its accelerated approval.

“It is gratifying to see the final confirmatory results of Trodelvy in a randomized study supporting the previously reported Phase 2 data that formed the basis of the accelerated approval of Trodelvy. These results provide important additional information for patients and their treating physicians to understand the definitive benefits they are deriving,” commented Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. “Importantly, the strong ASCENT data reinforce the promise of our unique ADC technology and embolden us to continue our work to change the treatment paradigm for patients with difficult-to-treat cancers.”

Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease.1

Conference Call

The Company will host a conference call and live audio webcast today at 8:00 a.m. Eastern Time to discuss the ASCENT data. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 8872919. The conference call will be webcast via the Investors page on the Company’s website at https://immunomedics.com/investors/. Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

About ASCENT

The international, open-label confirmatory Phase 3 study enrolled more than 500 patients with metastatic triple-negative breast cancer who had received at least two prior therapies for metastatic disease. Patients were randomized to receive either Trodelvy or a physician’s choice of chemotherapy. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response, time to onset of response, and other measures of safety and tolerability. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.

You May Also Be Interested In

• Ocugen (OCGN) Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 2 of Phase 1/2 ArMaDa Clinical Trial of OCU410—A Modifier Gene Therapy
• Cybin Inc (CYBN) Reports Publication of Research Manuscript in the Journal of Medicinal Chemistry
• Takeda (TAK) U.S. FDA Approves Subcutaneous Administration of ENTYVIO