Immunomedics (IMMU) is on the cusp of its first approval with the PDUFA date for sacituzumab
govitecan in metastatic triple negative breast cancer (mTNBC) set for 18 January 2019. As a small
company handling its first launch, management were keen to show that they are “launch ready”,
discussing the company’s operations and supply chain as well as partnerships it has made with
Samsung Biologics, Johnson Matthey, and BSP Pharmaceuticals to enable supply in case of
growing demand due to subsequent approvals. Immunomedics is in a strong cash position with
$583m cash and no long-term debt.
In terms of sacituzumab govitecan’s potential in mTNBC, the company outlined strong Phase II
data in which the therapy provided an overall response rate (ORR) of 33% and a progression-free
survival of 5.5 months, which compare well to data from other therapies for similar patient
groups. Head-to-head trial data is not yet available, though a Phase III comparative trial is
underway. Sacituzumab govitecan is under regulatory review for the treatment of mTNBC
patients who have received two prior therapies; this is a patient group who have few options and
where sacituzumab govitecan will likely be well-received. Indeed, the company stated its
intention to make sacituzumab govitecan the standard of care for third-line treatment.
The majority of the company’s remaining pipeline activity comprises of investigating sacituzumab
govitecan in other indications. A pivotal Phase II trial in advanced urothelial cancer was initiated
in June 2018, a pivotal Phase III trial in HR+/HER- breast cancer is planned for the first half of
2019, and a non-pivotal basket study investigating sacituzumab govitecan for refractory nonsmall cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, endometrial cancer, and hepatocellular carcinoma is planned for the second half of 2019. With a ikely launch and a busy clinical program, 2019 should be a good year for Immunomedics.
govitecan in metastatic triple negative breast cancer (mTNBC) set for 18 January 2019. As a small
company handling its first launch, management were keen to show that they are “launch ready”,
discussing the company’s operations and supply chain as well as partnerships it has made with
Samsung Biologics, Johnson Matthey, and BSP Pharmaceuticals to enable supply in case of
growing demand due to subsequent approvals. Immunomedics is in a strong cash position with
$583m cash and no long-term debt.
In terms of sacituzumab govitecan’s potential in mTNBC, the company outlined strong Phase II
data in which the therapy provided an overall response rate (ORR) of 33% and a progression-free
survival of 5.5 months, which compare well to data from other therapies for similar patient
groups. Head-to-head trial data is not yet available, though a Phase III comparative trial is
underway. Sacituzumab govitecan is under regulatory review for the treatment of mTNBC
patients who have received two prior therapies; this is a patient group who have few options and
where sacituzumab govitecan will likely be well-received. Indeed, the company stated its
intention to make sacituzumab govitecan the standard of care for third-line treatment.
The majority of the company’s remaining pipeline activity comprises of investigating sacituzumab
govitecan in other indications. A pivotal Phase II trial in advanced urothelial cancer was initiated
in June 2018, a pivotal Phase III trial in HR+/HER- breast cancer is planned for the first half of
2019, and a non-pivotal basket study investigating sacituzumab govitecan for refractory nonsmall cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, endometrial cancer, and hepatocellular carcinoma is planned for the second half of 2019. With a ikely launch and a busy clinical program, 2019 should be a good year for Immunomedics.
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