BeyondSpring’s Novel Study 103 Phase 3 Design in NSCLC To Be Presented at 2019 IASLC World Conference on Lung Cancer
Study 103, a Phase 3 global multi-center clinical trial, was undertaken in stage IIIB/IV, EGFR-wild type non-small cell lung cancer (NSCLC) patients [n=554], in 2nd and 3rd line therapy with Docetaxel plus Plinabulin, or Docetaxel in a 1:1 ratio.
NEW YORK, Sept. 10, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company’s novel design for Study 103 was selected for poster presentation at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in Barcelona, Spain. The poster, titled “DUBLIN-3, a Phase (Ph) III Trial Comparing the Plinabulin (P) / Docetaxel (D) Combination with D Alone in Stage IIIB / IV NSCLC,” was presented on September 9 from 10:15 a.m.-6:15 p.m. local time.
Study 103, a Phase 3 global multi-center clinical trial, was undertaken in stage IIIB/IV, EGFR-wild type non-small cell lung cancer (NSCLC) patients [n=554], in 2nd and 3rd line therapy with Docetaxel plus Plinabulin, or Docetaxel in a 1:1 ratio. Patients should have failed a prior line with a platinum-based regimen, and patients who had failed prior PD1/PD-L1 immunotherapy were allowed to enter the study. EGFR-wild type patients represent a severely underserved population, with a median overall survival (OS) at around 8-10 months, which is much shorter in comparison to patients with EGFR mutant, with a median OS at around 18 months. Even with PD-1/PD-L1 antibody treatment, only around 20 percent of these patients respond to treatment, leaving behind 80 percent of patients who require alternative therapies. Plinabulin is administered via 60 minutes of IV infusion and is given 1 hour after Docetaxel completion on Day 1. 450 patients have been enrolled in the study to date, and were treated with either:
- Arm 1: Plinabulin at 30mg/m2, administered on Day 1 and Day 8; and Docetaxel at 75 mg/m2 on Day 1 of each cycle;
- Arm 2: Docetaxel alone at 75mg/m2 on Day 1 of each cycle.
Plinabulin, a marine-derived, novel small-molecule, is BeyondSpring’s lead asset that activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the maturation of dendritic cells, which, in turn, leads to T-cell activation, in an antigen-specific manner. Plinabulin, combined with an antigen-generator, such as chemotherapy, facilitates antigen presentation by dendritic cells to T-cells, resulting in tumor cell killing. Antigens that can stimulate the immune system, which are also called immunogens, are more likely to induce immune cancer cell killing than antigens for which the immune system already has developed a tolerance. This type of immunogen is more likely to be found in earlier stage cancers, as opposed to more advanced cancers that have escaped immune surveillance.
BeyondSpring employed this principle in the design of Study 103 by selecting patients with a measurable lung lesion (per RECIST 1.1 criteria), with the requirement that the lesion is present in the lung, as opposed to in a distant organ, as these lung lesions likely represent novel sub-clonal lesions, which are likely to harbor novel antigens or immunogens that are still capable of stimulating the immune system. Measurable lung lesions (>1 cm with CT scan) located in the lung are expected to provide sufficient antigens after Docetaxel treatment for effective immuno-stimulation.
Patients with a measurable lung lesion, which represent more than 70 percent of NSCLC patients, currently have very few treatment options available to them in the 2nd and 3rd line. These patients typically have a low life expectancy and consider undergoing chemotherapy with the prospect of gaining only a few more months of life. However, this is typically at the expense of their Quality of Life (QoL) due to severe toxicities and can be an unattractive option. With the Plinabulin/Docetaxel combination, BeyondSpring aims to create a treatment option with not only a superior OS benefit, but also with a superior safety and QoL profile. Plinabulin is not only an anticancer agent, as clinical studies have demonstrated that it also prevents Docetaxel-induced toxicities such as severe neutropenia.
“The acceptance of this poster by the IASLC validates the novel trial design employed in Study 103. Based on the data at the first pre-planned interim analysis in n~350 patients with median OS as the primary endpoint, the DSMB concluded that the study could continue unmodified to the second pre-planned interim analysis, which is expected to be triggered later this year or early next year. If the Plinabulin/Docetaxel combination meets its target product profile of better efficacy, and with an improved safety and QoL profile than Docetaxel, the standard of care, it holds the promise of becoming the preferred 2nd and 3rd line treatment option in NSCLC, an area with significant unmet medical need, as PD1/PD-L1 immunotherapy has moved into 1st line treatment,” said Dr. Ramon Mohanlal, Chief Medical Officer and Executive Vice President, Research and Development, BeyondSpring.
About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
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