The clinical collaboration between Immunomedics Inc. and AstraZeneca and MedImmune for the development of Imfinzi (durvalumab) and sacituzumab govitecan combination therapy has been broadened to include second-line metastatic non-small cell lung cancer, the companies said.
“The combination study with durvalumab, together with our internal efforts to further develop sacituzumab govitecan monotherapy, will help us define the best registration strategies in NSCLC within accelerated timelines,” said Robert Iannone, head of research & development and chief medical officer of Immunomedics.
As CPIs increasingly move into front-line therapy, either alone or in combination with chemotherapy, treatment options for second-line and beyond are limited to single agent chemotherapies, which have only very modest activity. Thus, there is a high unmet need in NSCLC for patients who don’t respond or have progressed after treatment with CPIs.
Sacituzumab govitecan as monotherapy has produced an overall response rate of 19 percent in 47 patients with pretreated metastatic NSCLC with a duration of response of 6.0 months. In a subgroup of patients (14 of 47 patients) who had previously been treated with CPIs as their last line of therapy, ORR was 14 percent (2/14).
This open-label, multi-center phase I/II study will enroll two cohorts of patients, one in CPI primary refractory, and one in acquired resistance to CPI.
Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate. It is currently under priority review by the FDA for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who have received two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.
Durvalumab is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.
As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease.
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
