ImmunityBio Announces First Participants Have Been Enrolled in Lung-MAP Trial Studying Anktiva to Activate NK and T Cells in Non-Small Cell Lung Cancer
ImmunityBio (NASDAQ: IBRX) has enrolled the first participants in a significant clinical trial studying its IL-15 superagonist, Anktiva, combined with Keytruda for patients with non-small cell lung cancer (NSCLC) who have not responded to prior checkpoint inhibitors. This trial, part of the Lung Cancer Master Protocol, aims to enroll 478 patients across nearly 200 U.S. sites. With lung cancer being the second most common cancer in the U.S., the results could significantly impact treatment options and patient outcomes, offering a chemotherapy-free alternative.
- Enrollment of first participants in a major trial for Anktiva combined with Keytruda.
- Study involves 478 patients, enhancing potential market reach upon success.
- Aim to validate the effectiveness of Anktiva in patients resistant to checkpoint inhibitors.
- Potential to offer a chemotherapy-free treatment option, which may lead to better patient care.
- None.
- Novel combination therapy of Anktiva, an IL-15 superagonist, and Keytruda targeted at patients with lung cancer who have failed checkpoint inhibitor therapy
- The study currently includes nearly 200 U.S. sites and will involve 478 patients when fully enrolled
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Nearly 237,000 new cases of lung cancer estimated to be diagnosed in the
U.S. this year, making it the second most common cancer in theU.S.
“The Lung-MAP master protocol is an important and innovative national multicenter trial and we’re grateful to be working with this national network to validate our hypothesis that both NK and T cells are needed to establish durable responses in patients with lung cancer,” said
About the Anktiva (N-803) Lung-MAP Trial
The trial protocol is enrolling patients to a randomization schema of N-803 + pembrolizumab versus investigator choice of standard-of-care chemotherapy (docetaxel, gemcitabine, pemetrexed, or docetaxel + ramucirumab). The two cohorts are being studied independently: 1. Primary checkpoint inhibitor resistant patients, 2. Previous responders to checkpoint inhibitors who then subsequently progress.
The current standard-of-care for NSCLC without targetable mutations is pembrolizumab (Keytruda). This Lung-MAP study will look at how N-803 could potentially bolster the effectiveness of Keytruda for patients with non-targetable cancer cell mutations. The current standard of care for patients who progress on Keytruda is chemotherapy, which has significant toxicities associated with its use. Data presented by Wrangle and colleagues at ASCO 2021 showed the N-803/Keytruda combination as a chemotherapy-free alternative that has produced lower rates of adverse events than chemotherapy in the second-line setting https://ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.2596.
To learn more about the Lung-MAP study, please visit https://www.lung-map.org/patients or clinicaltrials.gov (NCT05096663).
“We are incredibly excited to begin a randomized trial of N-803 plus pembrolizumab compared to second line chemotherapy,” said John Wrangle, M.D., a researcher at the
Incidence of
According to the
ImmunityBio’s IL-15 superagonist Anktiva (N-803)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. Anktiva is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation. Compared to native, non-complexed IL-15 in vivo, Anktiva has better pharmacokinetic properties, due to longer persistence in lymphoid tissues, and enhanced anti-tumor activity.
Anktiva is currently being studied in 21 clinical trials across 14 indications.
About Lung-MAP
Launched in 2014, Lung-MAP, or the Lung Cancer Master Protocol, is a precision medicine clinical trial for people with advanced non-small cell lung cancer that has continued to grow after treatment. As the largest “umbrella” lung cancer trial in the
About
ImmunityBio’s clinical pipeline consists of 26 actively recruiting clinical trials—17 of which are in Phase 2 or 3 development—across 13 indications in liquid and solid tumors (including bladder, pancreatic, and lung cancers) and infectious diseases (including SARS-CoV-2 and HIV). Anktiva™, ImmunityBio’s lead cytokine fusion protein, is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the
The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams. For more information, please visit: www.immunitybio.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the information and data to be provided by the Lung-MAP trial, whether the combination of Anktiva with a checkpoint inhibitor could result in improved durable outcomes, the potential use and efficacy of ImmunityBio’s product candidates for the treatment of lung cancer, clinical trial protocol design, enrollment, advancement and potential results, and potential regulatory approval, commercialization and commercial success of ImmunityBio’s product candidates, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to
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