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Immunomedics (NASDAQ: IMMU) announced that the FDA has granted orphan drug status to Trodelvy (sacituzumab govitecan-hziy) for treating glioblastoma, an aggressive cancer. This designation aims to support development for underserved patient populations.
Dr. Loretta M. Itri emphasized Trodelvy's potential, citing encouraging early-stage study results, including partial responses in glioblastoma patients. The designation provides Immunomedics with various incentives, such as tax credits and market exclusivity post-approval.
Immunomedics (NASDAQ: IMMU) released promising results from the Phase 2 TROPHY U-01 study for Trodelvy in patients with metastatic urothelial cancer. The study showed a 27% overall response rate and a 5.9-month median duration of response among heavily-pretreated patients. Trodelvy has received Fast Track Designation from the FDA, with a sBLA submission for accelerated approval anticipated in Q4 2020. A Phase 3 study is also in progress. Patients previously had a median of 3 prior therapies.
Immunomedics announced that the Phase 3 ASCENT study results demonstrate that Trodelvy (sacituzumab govitecan-hziy) significantly increased overall survival in patients with metastatic triple-negative breast cancer (mTNBC). The median overall survival was reported at 12.1 months for Trodelvy compared to 6.7 months for standard chemotherapy, representing a 52% reduction in the risk of death. The company plans to submit a supplemental Biologics License Application in Q4 2020 for full approval. Trodelvy was well tolerated, maintaining a favorable safety profile.
Immunomedics announced promising early results for Trodelvy in treating brain tumors, specifically brain metastases from triple-negative breast cancer (BMBC) and recurrent glioblastoma (rGBM). In a study involving 19 patients, Trodelvy showed significant efficacy, with partial responses observed in both patient groups. Notably, it delivered concentrations of SN-38, the active drug, effectively across the blood-brain barrier. No new safety concerns were reported, highlighting the potential for further development of Trodelvy in aggressive brain cancers.
Immunomedics (NASDAQ: IMMU) announced five abstracts at ESMO Virtual Congress 2020, showcasing results from studies involving Trodelvy in metastatic triple-negative breast cancer and metastatic urothelial cancer. Key results include full ASCENT study findings and final TROPHY U-01 cohort results, along with initial findings of Trodelvy's effectiveness in brain tumors. A conference call with key opinion leaders will take place on September 19, 2020, to discuss these results and provide company updates.
MORRIS PLAINS, N.J., Sept. 02, 2020 – Immunomedics (NASDAQ: IMMU) announced that Dr. Behzad Aghazadeh will participate in two virtual healthcare conferences. The Wells Fargo Virtual Healthcare Conference is scheduled for September 9 at 8:40 a.m. ET, while the Morgan Stanley Virtual 18th Annual Global Healthcare Conference will take place on September 15 at 2:00 p.m. ET. Live webcasts of these events will be available on the Company's website, which will also include virtual meetings with institutional investors.
Immunomedics reported Q2 2020 net sales of $20.1M for Trodelvy, following its April FDA approval. The Phase 3 ASCENT study confirmed significant progression-free survival improvements in patients with metastatic triple-negative breast cancer. Key endpoints of overall survival and objective response rate were also met. The company anticipates filing a supplemental Biologics License Application for full approval of Trodelvy by Q4 2020. As of June 30, 2020, Immunomedics had $975.5M in cash, signaling strong financial health for ongoing and future clinical developments.
Immunomedics (NASDAQ: IMMU) announced an extension of its clinical collaboration with Roche to study Trodelvy, an anti-Trop-2 antibody-drug conjugate, in combination with Roche’s Tecentriq for patients with metastatic urothelial cancer and non-small cell lung cancer. The studies will evaluate the efficacy of this combination compared to standard treatments. Additionally, patient enrollment has begun for the Phase 2 NeoSTAR study focusing on localized triple-negative breast cancer, with pathological complete response as the primary endpoint.
Immunomedics announced that its Phase 3 ASCENT study of Trodelvy (sacituzumab govitecan-hziy) improved progression-free survival (PFS) and overall survival (OS) in previously treated metastatic triple-negative breast cancer (mTNBC) patients without brain metastasis. Trodelvy achieved a median PFS of 5.6 months versus 1.7 months for chemotherapy, with a hazard ratio of 0.41 (p<0.0001). The safety profile remained consistent with prior reports, with no new safety signals. A supplemental biologics license application for full approval is planned for later this year.
MORRIS PLAINS, N.J., July 2, 2020 – Immunomedics (NASDAQ: IMMU) announced a conference call on July 6, 2020, at 8:00 a.m. ET to provide a clinical update. Interested parties can join by dialing (877) 303-2523 or (253) 237-1755 with Conference ID 8872919. A live audio webcast will also be available on the Company's website. Immunomedics specializes in antibody-drug conjugates for treating cancer, with its lead product, Trodelvy, being the first clinical ADC approved for metastatic triple-negative breast cancer.
