Zai Lab and Novocure Announce LUNAR Phase 3 Clinical Trial Demonstrates Statistically Significant and Clinically Meaningful Extension in Overall Survival for Patients with Metastatic Non-Small Cell Lung Cancer After Platinum-Based Therapies
Tumor Treating Fields therapy together with standard of care provided a statistically significant and clinically meaningful 3-month improvement in median overall survival versus standard of care with no added systemic toxicities
Tumor Treating Fields therapy together with immune checkpoint inhibitors resulted in an unprecedented 8-month improvement in median overall survival
LUNAR is the first phase 3 clinical trial in more than seven years to show a significant extension in overall survival in metastatic non-small cell lung cancer post-platinum therapy
Data from the LUNAR trial to be presented today during the 2023 ASCO Annual Meeting
Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). A profound OS benefit from TTFields therapy was demonstrated in the immune checkpoint inhibitor (ICI) subgroup. Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with ICIs alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.
“The results of the LUNAR study are highly encouraging,” said primary investigator
“The significant improvement in overall survival as demonstrated in the LUNAR study is groundbreaking. Lung cancer is the leading cause of cancer-related death in
Baseline characteristics were well balanced between cohorts: median age was 64 years (range, 22-86); 65% male; 96% of patients had an ECOG performance status of 0-1. Patients were enrolled at sites in
Of patients randomized, 89% had one prior line of systemic therapy and 31% of patients randomized had been treated with an ICI (58% of patients randomized to the docetaxel cohort and 2% of patients randomized to the ICI cohort). ICIs were approved for first-line NSCLC in 2017 during the conduct of the LUNAR study, and PD-L1 expression data were collected thereafter in geographic regions where ICIs had been adopted. Tumor Proportion Scores were available for 151 patients globally (55%) and were well balanced across the cohorts. In all patients treated with ICI and with measured Tumor Proportion Scores, 63% had PD-L1 expression >1%, which is in-line with real-world data. PD-L1 expression data were collected from 83% of patients (69 of 83 patients) enrolled at
|PD-L1 Expression||TTFields + SOC (n=137)||SOC
|TTFields + ICI (n=66)||ICI
|TTFields + DTX (n=71)||DTX
DTX = docetaxel; ICI = immune checkpoint inhibitor; SOC = standard of care
Novocure has submitted the LUNAR clinical trial results for publication in a leading, peer-reviewed medical journal. The LUNAR clinical trial data are expected to serve as the basis for a Premarket Approval (PMA) submission to the
“I would like to thank our patients, their families and caregivers for participating in the LUNAR trial,” said
“Each year in
Novocure is dedicated to advancing TTFields therapy for patients with solid tumors. The LUNAR clinical trial is the first of four phase 3 clinical trials expected to readout by the end of 2024 studying the use of TTFields therapy for the treatment of solid tumors of the brain, torso and abdomen. Based on the strength of the LUNAR data, Novocure intends to launch additional phase 3 trials evaluating TTFields therapy in earlier lines of treatment and together with ICIs and other standards of care.
In addition to LUNAR,
Investor Event details
Novocure will host an investor event at
LUNAR is a phase 3 trial testing the safety and effectiveness of TTFields therapy when used together with ICI or docetaxel (experimental arm) versus ICI or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy. The primary endpoint is superior overall survival of patients treated with TTFields therapy plus ICI or docetaxel versus ICI or docetaxel alone. The powered secondary endpoints are superior overall survival of patients treated with TTFields therapy plus ICI versus ICI cohort and superior overall survival of patients treated with TTFields therapy plus docetaxel versus docetaxel alone. TTFields therapy is intended principally for use with other concomitant standard of care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful.
About NSCLC in
Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root,
Novocure Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on
For additional information about
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about future expectations, plans, and prospects, including, without limitation, statements relating to Tumor Treating Fields, the LUNAR study, and the potential treatment of patients with non-small cell lung cancer. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and results of operations, (6) risks related to doing business in
For more information, please contact:
Source: Zai Lab Limited