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Immunomedics' Shares Rise on Positive Breast Cancer Drug Data

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Shares of Immunomedics Inc. grew 8.2% after the confirmatory phase III study of its breast-cancer drug, Trodelvy (sacituzumab govitecan-hziy), met its primary and secondary endpoints. Moreover, shares of the company have surged 92% year to date compared with the industry’s growth of 11.7%.

The ASCENT study was conducted on brain metastasis negative patients with metastatic triple-negative breast cancer (mTNBC) who had previously received at least two prior therapies for metastatic disease.

In the study, Trodelvy demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to chemotherapy, with a hazard ratio of 0.41. The median PFS for patients treated with Trodelvy was 5.6 months compared to 1.7 months for chemotherapy.

The drugalso met key secondary endpoints inthe study, including overall survival and objective response rate.

The data suggest that Trodelvy has set a new benchmark for patients with mTNBC by offering a novel alternative to the common drugs currently in use. The data also validates the manageable safety profile of Trodelvy, thus making it a good option for a partner candidate for combination with other therapies, including immunotherapy.

The phase III results support the previously reported phase II data that formed the basis of the accelerated approval of Trodelvy.

We remind investors that in April, Trodelvy obtained accelerated approval from the FDA for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC), who have received at least two prior therapies for metastatic disease. Trodelvy is the first antibody-drug conjugate (ADC) approved by the FDA specifically for previously-treated mTNBC and also the first FDA-approved anti-Trop-2 ADC.

The drug is also being evaluated for additional indications. The FDA recently granted a Fast Track designation to sacituzumab govitecan for the treatment of adult patients with locally-advanced or metastatic urothelial cancer (mUC).

Meanwhile, Immunomedics also collaborated with few companies for further development of Trodelvy. Itcollaborated with the  Dana-Farber Cancer Institute to conduct two phase II studies to evaluate the safety and efficacy of combining Trodelvy with Merck’s (MRK - Free Report) anti-programmed cell death protein 1 (PD-1) antibody, Keytruda (pembrolizumab), in patients with mTNBC and hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC).

The company also entered two clinical collaborations. It collaborated with Roche (RHHBY - Free Report) to develop Trodelvy in the front-line setting of mTNBC in combination with the latter’s PD-L1 inhibitor, Tecentriq.

The company has a similar collaboration agreement with AstraZeneca (AZN - Free Report) to investigate Trodelvy in combination with the latter’s checkpoint inhibitor, Imfinzi (durvalumab), in earlier lines of therapy for mTNBC, advanced UC and second-line metastatic NSCLC.

These collaborations are constant sources of funds for the company.

 

Zacks Rank

Immunomedics is currently a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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