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Immunomedics Extends Deal With Roche for Two New Studies

Immunomedics Inc. IMMU announced that it will extend its clinical collaboration with Roche RHHBY with two new studies evaluating the combination of anti-Trop-2 antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) of the former and the latter’s Tecentriq (atezolizumab) in patients with metastatic urothelial cancer (mUC) and metastatic non-small cell lung cancer (mNSCLC). Tecentriq is Roche’s programmed cell death ligand 1 (PD-L1)-blocking checkpoint inhibitor (CPI).

Immunomedics already collaborated with Roche in 2019 to develop Trodelvyin for the frontline setting of triple-negative breast cancer (mTNBC) in combination with the latter’s Tecentriq.

Shares of the company have increased 88.9% year to date compared with the industry’s growth of 6.4%.

We remind investors that in April 2020, Trodelvy obtained accelerated approval from the FDA for the treatment of adult patients with metastatic mTNBC, who have received at least two prior therapies for metastatic disease. Trodelvy is the first ADC approved by the FDA specifically for previously-treated mTNBC and also the first FDA-approved anti-Trop-2 ADC.

Per the agreement, Roche will conduct two open-label, randomized phase Ib/II studies using its MORPHEUS platform.

MORPHEUS-mUC will randomize checkpoint inhibitor (CPI)-naive mUC patients who have failed to respond to platinum-based chemotherapy to receive either the Tecentriq plus Trodelvy combination or Tecentriq alone.

The second study-MORPHEUS-Lung will randomize CPI-experienced mNSCLC patients who failed to respond to platinum-based regimens to receive either the Tecentriq and Trodelvy combo or docetaxel alone.

Further, Immunomedics announced that the new phase II NeoSTAR study enrolled the first patient with localized TNBC to receive Trodelvy before surgery to remove the tumor. The primary endpoint of this study is pathological complete response rate while disease-free survival and overall survival are the secondary endpoints.

We remind investors that Immunomedics also collaborated 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 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 has a similar collaboration agreement with AstraZeneca AZN 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.

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

 

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