Phase 2 Platform Study to Evaluate the Combination of Imfinzi® (Durvalumab) and Sacituzumab Govitecan in Patients with Non-Small Cell Lung Cancer Who Progressed on or after Immune Checkpoint Inhibitor Therapy
MORRIS PLAINS, N.J., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced its current clinical collaboration with AstraZeneca (NYSE: AZN) 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 (NSCLC).
“Sacituzumab govitecan has shown very encouraging single-agent activity in NSCLC patients who have failed multiple lines of therapy. 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 Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics.
Immune checkpoint inhibitors (CPI) have drastically changed the treatment landscape in NSCLC and significantly improved patient outcomes. However, there is still a substantial proportion of patients who don’t benefit from CPIs. 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.
Hesham Abdullah, Head of Immuno-Oncology, Global Medicines Development, AstraZeneca said, “The efficacy, safety and tolerability of durvalumab in NSCLC and the clinical activity of sacituzumab govitecan monotherapy in late-line NSCLC, provide promising rationale for the development of the durvalumab and sacituzumab govitecan combination in the metastatic setting. We are excited about the potential of this combination in second-line NSCLC, which may fill an important unmet medical need for patients who desperately need new treatment options.”
Sacituzumab govitecan as monotherapy has produced an overall response rate (ORR) of 19% 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% (2/14).1
This open-label, multi-center Phase 1/2 study will enroll two cohorts of patients, one in CPI primary refractory, and one in acquired resistance to CPI.
- Heist RS, Guarino MJ, Masters G, et al. Therapy of advanced non-small-cell lung cancer with an SN-38-anti-Trop-2 drug conjugate, sacituzumab govitecan. J Clin Oncol. 2017 Aug 20;35(24):2790-2797.
About lung cancer
According to the National Cancer Institute, more than 234,000 Americans are estimated to be diagnosed with lung cancer in 2018 and approximately 154,000 lung cancer patients will die from the disease. NSCLC is the most common type of lung cancer, accounting for about 84 percent of all lung cancer cases. It is estimated that approximately 57 percent of lung cancer diagnoses in the United States are made when the disease has metastasized. The five-year relative survival rate for patients suffering from metastatic lung cancers is estimated to be 4.7 percent.
About Sacituzumab Govitecan
Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under priority review by the U.S. Food and Drug Administration 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.
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer. Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.
Cautionary note regarding forward-looking statements
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the filing and approval timelines for BLAs and BLA supplements, out-licensing arrangements, forecasts of future operating results, potential collaborations, capital raising activities, and the timing for bringing any product candidate to market, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.