BeiGene Presents Phase 3 Data on Tislelizumab Combined with Chemotherapy for the Treatment of Patients with Advanced Squamous Non-Small Cell Lung Cancer at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program
- Phase 3 results comparing tislelizumab plus chemotherapy to chemotherapy alone met its primary endpoint
- Company to host investor conference call and webcast on ASCO clinical updates on
Friday, May 29at 8:00 p.m. ET
“The results from this Phase 3 trial demonstrated that inhibiting the PD-1 pathway with tislelizumab, combined with standard chemotherapy, provided a clinically meaningful benefit to patients with advanced squamous NSCLC, as assessed by progression-free survival and response rates,” said
“We are excited to share data from this trial, which were included in our supplemental new drug application currently under review by the
Tislelizumab was evaluated as a first-line treatment in advanced squamous NSCLC in combination with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®i) and carboplatin compared with paclitaxel and carboplatin alone in an open-label, multi-center Phase 3 trial (NCT03594747) in
As of data cutoff on
- The trial achieved the primary endpoint of progression-free survival (PFS) as assessed by Independent Review Committee (IRC); PFS was significantly improved with tislelizumab plus chemotherapy (Arms A and B) compared with chemotherapy alone (Arm C), regardless of tumor cell PD-L1 expression. Across all arms, median overall survival was not reached, and median number of treatment cycles were comparable;
- Median PFS was 7.6 months for both tislelizumab arms compared to 5.5 months for chemotherapy alone. The hazard ratio (HR) for the comparison of Arm A vs. Arm C was 0.52 (95% confidence interval (CI), 0.4-0.7; p=0.0001), the HR for the comparison of Arm B vs. Arm C was 0.48 (95% CI, 0.3-0.7; p <0.0001);
- Additionally, the objective response rates (ORR) were meaningfully higher for patients receiving tislelizumab; ORRs were 73% (95% CI 64%-80%) and 75% (66%-82%) in Arm A and Arm B, respectively versus 50% (40% - 59%) in Arm C;
- Treatment with tislelizumab plus chemotherapy also roughly doubled the median duration of response (DoR) compared to chemotherapy alone. In the tislelizumab cohorts, DoR was 8.2 months for Arm A and 8.6 months for Arm B, while DoR in the Arm C was 4.2 months;
- Treatment with tislelizumab and chemotherapy was generally well-tolerated in patients with NSCLC and in line with the known safety profiles of tislelizumab, chemotherapy, and underlying NSCLC. No new safety signals were identified with the addition of tislelizumab to chemotherapy;
- Most treatment-related AEs (TRAEs) were mild or moderate in severity; the most common TRAEs (≥ 20%) of any grade in all patients were (Arm A, Arm B, Arm C, respectively) hematologic in nature and included anemia (82.5%; 88.1%; 74.4%), alopecia (64.2%; 68.6%; 61.5%), decreased neutrophil count (62.5%; 61.0%; 58.1%), decreased white blood cell count (52.5%; 57.6%; 53.0%), leukopenia (47.5%; 55.9%; 47.9%), neutropenia (42.5%; 42.4%; 47.0%), and decreased appetite (41.7%; 41.5%; 29.9%);
- Serious treatment-related AEs (TRAEs) were reported in 27 patients in Arm A, 28 patients in Arm B and 17 patients in Arm C; serious TRAEs reported in Arm A and Arm B, respectively, included decreased neutrophil count (n=4; n=4), febrile neutropenia (n=2; n=3), pneumonitis (n=3; n=2), leukopenia (n=2; n=1), increased blood creatine phosphokinase (n=2 [Arm B]), decreased platelet count (n=1; n=2), bone marrow failure (n=2; n=1), rash (n=2 [Arm A]), and pyrexia (n=2 [Arm A]). The most commonly reported TRAEs in Arm C were thrombocytopenia (n=3) and decreased neutrophil count, decreased white blood cell count, and septic shock (n=2 each);
- Tislelizumab-related grade ≥3 AEs occurred in 36.7% and 40.7% of patients in Arm A and Arm B, respectively;
- Treatment-emergent AEs (TEAEs) leading to death were reported in 4 patients (3.3%) in Arm A, 5 patients (4.2%) in Arm B, and 5 patients (4.3%) in Arm C; and
- Potential immune-mediated AEs occurred in 51.7% (A), 47.5% (B), and 18.8% (C) of patients. Most were low grade, did not require corticosteroid treatments, and did not lead to discontinuation of any treatment component. The most commonly reported immune-mediated AE was pneumonitis; grade ≥3 pneumonitis occurred in 2.5%, 3.4%, and 0.9% of patients in Arms A, B, and C, respectively.
Investor Conference Call
The Company will host an investor conference call and webcast on
A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at http://ir.beigene.com or http://hkexir.beigene.com. An archived replay will be available for 90 days following the event.
To learn more about BeiGene’s pipeline and data presented during the ASCO2020 Virtual Scientific Program, visit BeiGeneVirtualCongress.com.
About Non-Small Cell
In contrast to most Western countries where lung cancer death rates are decreasing, the lung cancer incidence rate is still increasing in
Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
Tislelizumab is approved by the China National Medical Products Administration as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Additionally, the
Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.
Tislelizumab is not approved for use outside of China and is not approved to treat non-small cell lung cancer.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from ongoing clinical trials of tislelizumab, the mechanism of action of tislelizumab, BeiGene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of tislelizumab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
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i ABRAXANE® is a registered trademark of
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v Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin 2012;62:220-41.
Source: BeiGene, LTD.