Billions Pouring Into Drugs That Could Treat Cancer Patients with High TROP2 Expressions - Seite 2

While also being in Phase 1 clinical development for treating non-small cell lung cancer (NSCLC), in July Daiichi Sankyo expanded its Phase 1 study for DS-1062 to include patients with advanced/unresectable or metastatic TNBC.

Should Daiichi (and now AstraZeneca) succeed with DS-1062, it won't be the first drug targeting TROP2 to win FDA approval.

Immunomedics, Inc. (NASDAQ:IMMU) won that distinction in April, when the FDA authorized its lead ADC Trodelvy (sacituzumab govitecan-hziy) as a treatment for adults with metastatic TNBC who had at least received two prior therapies for metastatic disease. Trodelvy officially became the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC, and is also the first FDA-approved anti-Trop-2 ADC.

The company recently reported encouraging early adoption of Trodelvy in the US, with $20.1 million in net sales during the first two months of launch.

BIG BETS BEING MADE

AstraZeneca's (NYSE:AZN) recent deal with Daiichi Sankyo will have the pharma giant paying out $1 billion to co-develop an ADC called DS-1062 outside of Japan. The deal also features a further $5 billion in milestones, with the bet being made that it can hit the same target as Trodelvy.

Now the market's hope is that platforms such as DS-1062 and others such as pelareorep can capitalize on similar successes as Trodelvy. It was results such as 33.3% of all patients that received Trodelvy experiencing a certain amount of shrinkage of their tumors that led to the drug's approval.

Immunomedics, Inc. also recently announced that the FDA also approved Samsung Biologics to produce commercial-scale hRS7, the antibody used in Trodelvy, at its manufacturing facilities in Incheon, South Korea. The approval is said to enhance Immunomedics' long-term supply of Trodelvy.

Previously, pharma giant Pfizer Inc. (NYSE:PFE) had also taken an anti-TROP2 ADC into the clinic but (according to Fierce Biotech) scrapped the trial after seeing early data, which left Trodelvy and DS-1062 as the front-runners. However, in late July, a partner of Pfizer announced that "very good progress" was being made on its own TNBC trial for a compound called ZEN-3694. 

At the end of July, Merck & Co., Inc. announced two US regulatory milestones for its drug KEYTRUDA (pembrolizumab) in TNBC. First off the FDA granted priority review to KEYTRUDA's Supplemental Biologics License Application (sBLA) when combined with chemotherapy for the treatment of certain patients with metastatic TNBC based on the Phase 3 KEYNOTE-355 trial. The FDA also accepted an sBLA for KEYTRUDA for the treatment of patients with high-risk early-stage TNBC based on the Phase 3 KEYNOTE-522 trial.