Immunomedics, Inc. (NASDAQ:IMMU) posted $20.1 million in revenues in Q2 2020 from the sale of Trodelvy after receiving accelerated approval from the US FDA in April 2020. It’s spending on R&D declined to $42.6 million in Q2 2020.
Trodelvy demonstrates topline performance
EC of Immunomedics, Behzad Aghazadeh, said the company accomplished significant milestones in Q2 2020. Patients and physicians have well-accepted Trodelvy because of excellent benefits and lower risk profile. The drug provided topline results in the ASCENT clinical trial.
Immunomedics expects to receive full data readouts of the Trodelvy from Trophy U-01 clinical trial in mUC (metastatic urothelial cancer). It also expects full data from the ASCENT study of Trodelvy. The company is putting in significant efforts to provide a meaningful treatment option to improve people’s lives suffering from hard to cure cancer types.
Trodelvy generated sales of $20.1 million within two months of the launch. It is on the backdrop of wide use by physicians in academic settings and communities. In Phase 3 clinical trial, the drug showed better performance in improving PFS (Progression-Free Survival).
The patients, who have received Trodelvy treatment, have improved PFS by 5.6 months. Immunomedics also achieved a secondary endpoint of ORR (Objective Response Rate) and OS (Overall Survival). The safety profile of the drug complies with the FDA’s approved label. Immunomedics expects to submit the ASCENT study results in SBLA (supplemental Biologics License Application) in Q4 2020 for full approval of the drug from the FDA. It will submit the ASCENT study results in Q1 2021 to EMA (European Medicines Agency).
Immunomedics will also present topline data from ASCENT study to ESMO (European Society for Medical Oncology) virtual congress 2020. Trodelvy received acceptance from ESMO Congress for oral presentation in treating central nervous system tumors.
FDA approves Samsung Biologics
The US FDA approved Samsung Biologics for the production of antibodies for Trodelvy. Samsung Biologics can now manufacture hRS7, used in sacituzumab govitecan-hziy, at its production facilities located in Incheon, South Korea.
SVP (Global product supply), John Stubenrauch said the company expressed gratitude to the FDA to expedite prior approval supplements. It allows the company to hit the US market with the commercial product. Trodelvy is the first product to receive the FDA’s approval to cure patients suffering from MTN (metastatic triple-negative) breast cancer.