BeyondSpring’s PROTECTIVE-2 (Study 106) Phase 2 Trial for Chemotherapy-Induced Neutropenia Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes
June 11, 2020
– Plinabulin in Combination with Neulasta Improves Dose and Regimen Compliance of TAC Chemotherapy Compared to Neulasta Alone –
– Chemotherapy Dose Reduction and Regimen Downgrade Significantly Impacts Long-term Survival –
NEW YORK, June 09, 2020 (GLOBE NEWSWIRE) — BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that its PROTECTIVE-2 (Study 106) Phase 2 superiority trial for chemotherapy-induced neutropenia (CIN) shows that the Company’s lead asset, Plinabulin, in combination with Neulasta, enables more cancer patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes.
“Clinical research demonstrates that patients who receive over 85 percent of the optimal chemotherapy dose on time have significantly better overall survival1,” said Dr. Lan Huang, BeyondSpring’s CEO and Co-Founder. “Additionally, monotherapy G-CSF has been shown to help some patients maintain chemotherapy regimens. However, in an analysis of over 16,000 patients with monotherapy G-CSF, very few patients are able to maintain their targeted regimen2. It is clear that oncologists and patients need more tools to stay the course for improved survival3.”
PROTECTIVE-2 evaluated superiority potential in the prevention of CIN in breast cancer patients treated with docetaxel, doxorubicin and cyclophosphamide (TAC, a high-risk chemotherapy) with 20mg/m2 of Plinabulin combined with 6mg of Neulasta (a long-lasting G-CSF and the standard of care for CIN) (n=16) compared with 6mg of Neulasta alone (n=22).
Plinabulin + G-CSF improves compliance with targeted chemotherapy:
Dose reduction (over 15 percent):
Only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm – a 72 percent improvement
A chemotherapy dose reduction of over 15 percent leads to a 50 percent survival reduction4
Downgraded regimen (from TAC to TC):
No (0 percent) patients in the Plinabulin + G-CSF arm downgraded chemotherapy from the TAC regimen to the TC regimen versus 18.2 percent in the Neulasta arm –p < 0.05 TAC with an objective response rate (ORR) at 83 percent5 is a more effective chemotherapy regimen than TC with an ORR at 42 percent6
Grade 4 neutropenia occurs in as many as 52 percent of patients who are undergoing high-risk chemotherapy3, even with G-CSF treatment, and is the primary reason for changes in chemotherapy regimens (i.e., decreasing, delaying, downgrading or discontinuing chemotherapy treatment, or the 4D’s1).
“Having the ability to greatly reduce Grade 4 neutropenia means that oncologists can optimize cancer patients’ chemotherapy regimens, turning the 4Ds into the 4Ss: stable doses, sustained cycles and the strongest regimens, allowing patients to stay the course,”
added Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development. “This approach provides potential benefits for both clinicians and patients: clinicians may gain greater control over cancer care, and patients may experience better clinical outcomes and an improved quality of life. The improvement in the prevention of Grade 4 neutropenia that is seen with the Plinabulin-Neulasta combination is even more important in today’s healthcare environment due to the devastating impact of COVID-19 on immune-suppressed patients. We look forward to the upcoming Phase 3 interim topline data readout for PROTECTIVE-2, which represents an important milestone to potentially serve as a new standard of care in CIN treatment.”
1Lalami et al. Critical Reviews in Oncology / Hematology 120: 163-179 (2017)
2 Lyman et al. JNCCN 13(11): 1382-1393 (2015)
4 Bonadonna G et al. N Engl J Med 332:901-906 (1995)
5 O’Regan et al. Clinical Breast Cancer 6(2): 163-168 (2005)
6 Vasey et al. British J Cancer 87: 1072-1078 (2002)
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin as an immune and stem cell modulator, 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. BeyondSpring is headquartered in New York City.
Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN with a rapid onset, but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.
About Plinabulin in PROTECTIVE-2 (Study 106) CIN Study
Study 106 was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with Plinabulin (40mg, Day 1 dose) + Neulasta (6mg, Day 2 dose) versus a single dose of Neulasta (6mg, Day 2). TAC is one example of high-risk chemotherapy. Plinabulin and G-CSF have complementary mechanisms in preventing CIN. This is a superiority study in CIN efficacy in prevention of Grade 4 neutropenia, comparing the combination head-to-head against Neulasta and is currently enrolling. Literature shows that the Grade 4 neutropenia rate for TAC and Neulasta at 6mg is 83 to 93 percent, which presents severe unmet medical needs.
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.</p?
RECENT NEWS ARTICLES
BeyondSpring Strengthens Board with the Addition of Ex-Immunomedics and Constellation Commercial Head Brendan Delaney
NEW YORK, July 14, 2021 -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced the appointment of Brendan Delaney to its Board of Directors, effective...
NEW YORK, July 08, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (“BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that management will participate in the William Blair Biotech...
BeyondSpring to Host R&D Day to Discuss Novel Immune Agent Plinabulin’s Development Program in Anti-cancer Indications
NEW YORK, June 17, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced it will host a Research and Development...
- NDA Filed by U.S. Food and Drug Administration (FDA) and given Priority Review for plinabulin plus G-CSF for the prevention of CIN. A PDUFA date of November 30, 2021 has been assigned by the FDA - Highlighted PROTECTIVE-2 Phase 3 data at two scientific conferences –...
BeyondSpring to Host First Quarter Financial Results and Corporate Update Conference Call on June 16, 2021
NEW YORK, June 11, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (“BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that management will host a conference call to report its...
BeyondSpring Announces Final Positive Data from the PROTECTIVE-1 Phase 3 CIN Program of Plinabulin as a Single Agent Compared to Pegfilgrastim at the American Society of Clinical Oncology (ASCO) Annual Meeting
- Data further supports plinabulin’s fast onset of action and CIN prevention benefit in week 1 following chemotherapy - Single agent plinabulin (day 1 dose as chemotherapy), had non-inferior protection against CIN compared to pegfilgrastim (day 2 dose), while...
BeyondSpring Announces a Late-Breaking Poster Presentation of PROTECTIVE-2 Phase 3 Data Showing Plinabulin, in Combination with Pegfilgrastim, Reverses the Immune-Suppressive Effects of Pegfilgrastim and Offers Superior Prevention of Chemotherapy-Induced Neutropenia (CIN) at the FOCIS Annual Meeting
Presentation data demonstrates that plinabulin, in combination with pegfilgrastim, not only improves CIN prevention but also reverses some of the immune suppressive profile of monotherapy pegfilgrastim NEW YORK, June 08, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the...
BeyondSpring Announces Three Presentations Highlighting Positive Clinical Outcome Data from the Phase 3 Program of Plinabulin in Combination with Pegfilgrastim for the Prevention of Chemotherapy-Induced Neutropenia at the American Society of Clinical Oncology (ASCO) Annual Meeting
- Data demonstrate that combination of plinabulin and pegfilgrastim offers superior benefit for reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone NEW YORK, June 07,...
BeyondSpring Announces First Patient Dosed in a Triple Combination Study with Plinabulin, PD-1/PD-L1 Inhibitor and Radiotherapy for the Reversal of Resistance to PD-1/PD-L1 Inhibitors in Patients with Advanced Solid Tumors
Resistance to immunotherapy is a severe unmet medical need that plinabulin aims to address in combination with checkpoint inhibitors and radiotherapy First patient who failed Keytruda and chemotherapy has been dosed with plinabulin, Keytruda and radiation combination...
BeyondSpring Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Plinabulin and G-CSF Combination for the Prevention of Chemotherapy-Induced Neutropenia (CIN)
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2021 - Plinabulin and G-CSF combination has the potential to raise the standard of care in CIN prevention for the first time in 30 years NEW YORK, June 01, 2021 (GLOBE...
RECENT MEDIA COVERAGE
Seed Therapeutics Launches Protein Degradation Research Platform and Appoints Edward Dongheng Liu as Chief Financial Officer
JAMA Oncology Highlights Plinabulin’s Efficacy in Preventing Chemotherapy-Induced Neutropenia as a Monotherapy