Immunomedics, Inc. (NASDAQ:IMMU), a clinical-stage biopharmaceutical company, today declared that sacituzumab govitecan, its lead investigational antibody-drug conjugate (ADC), produced meaningful clinical benefit in patients with relapsed or refractory metastatic urothelial cancer. Among the 19 patients enrolled into the open-label Phase 2 study, at the time of analysis the interim median PFS was 6.9 months, based on RECIST 1.1, and interim mean OS was 11.4 months, with 84% of patients still alive. Expression of Trop-2, a cell-surface protein targeted by the ADC, is not a pre-selection criterion for patient enrollment.
“To put these results with IMMU-132 in perspective, multiple chemotherapy regimens have been stated to produce PFS of 2 to 5 months and OS of 4 to 9 months in the second- or third-line setting of metastatic urothelial cancer1,” commented Scott T. Tagawa, M.D., Medical Director, Genitourinary Oncology Research Program, Weill Cornell Medicine/New York-Presbyterian Hospital, New York, NY, who presented the updated results at the AACR conference.
Of the fourteen assessable patients who had received a median of 2 (range, 1 – 5) prior lines of chemotherapy, seven patients stated a fractional response as their best response, yielding an interim ORR of 50%. Prominently, six of the seven responding patients (86%) had been confirmed with a follow-up computed tomography (CT) scan, four of whom are continuing with their treatment.
As has been stated by us in patients with other types of solid cancer, sacituzumab govitecan also has an acceptable interim safety profile in 13 urothelial cancer patients stated at AACR. The notable adverse events were Grade 3 or 4 neutropenia and febrile neutropenia in 31% and 15% of patients, respectively. Severe diarrhea, commonly stated with irinotecan, was rare, with only 8% Grade 3/4 incidents. More importantly, repeated doses can be given over months without evoking interfering anti-sacituzumab govitecan antibodies from patients’ own immune system.
“We are very confident by these results in metastatic urothelial cancer, which warrant a regulatory strategy similar to triple-negative breast cancer should these results continue to be robust,” remarked Cynthia L. Sullivan, President and Chief Executive Officer. “Updated results in triple-negative breast and non-small-cell lung cancers will be presented at two Clinical Science Symposia during the forthcoming ASCO Annual Meeting in June.”
Sacituzumab govitecan has received Breakthrough Therapy designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed prior therapies for metastatic disease.
On Tuesday, Shares of Immunomedics Inc. (NASDAQ:IMMU), lost -1.69% to $2.90. Trading volume recorded for this company is about 771,994 shares as contrast to its average volume of 858,075 shares. The share price surged almost 10.90% in the last one month. The stock’s intraday range is $2.86 to $3.04. The company has the total of 95.42M outstanding shares, while its market capitalization is about $274.75M.
