BeOne Medicines Presents Phase 3 Data for CLL in Elderly Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 11 2026
0mins
BeOne Medicines announced the presentation of a large Phase 3 dataset in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, CLL/SLL, aged 80 and older, showing sustained benefit with Brukinsa after nearly 6.5 years of follow-up, reinforcing its role as the foundational BTK inhibitor. Brukinsa is the only BTK inhibitor to demonstrate superior efficacy vs. ibrutinib in a Phase 3 trial. These data, one of the largest datasets of older patients with treatment-naive CLL, will be presented at the 2026 European Hematology Association, EHA, Congress in Stockholm, Sweden. Key highlights: Sequoia subgroup analysis showed that age did not limit benefit in patients with CLL treated with Brukinsa; 78-month Sequoia data reinforce Brukinsa as the "foundational BTK inhibitor" in CLL; Real-world efficacy and safety data consistently underscore "foundational Brukinsa as the best-in-class BTKi" for TN CLL
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Analyst Views on ONC
Wall Street analysts forecast ONC stock price to rise
11 Analyst Rating
11 Buy
0 Hold
0 Sell
Strong Buy
Current: 262.680
Low
385.00
Averages
403.76
High
424.00
Current: 262.680
Low
385.00
Averages
403.76
High
424.00
About ONC
BeOne Medicines AG, formerly BeiGene, Ltd., is a global oncology company engaged in discovering and developing treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, the Company is engaged in the development of its diverse pipeline of novel therapeutics. Its products include Brukinsa, Tevimbra and Pamiparib. Brukinsa is an orally available, small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Tevimbra is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcy) receptors on macrophages, helping the body’s immune cells detect and fight tumors. The Company’s product pipeline in development includes Sonrotoclax, Tarlatamab, Zanidatamab, Blinatumomab, BGB-26808, BGB-R046, BG-68501, BG-C9074, BGB-43395, Xaluritamig, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
BeOne's Drug Shows Durable Efficacy in Chronic Lymphocytic Leukemia
- Significant Efficacy: Tacabrutideg demonstrated an overall response rate of 85.1% in heavily pretreated relapsed/refractory chronic lymphocytic leukemia (CLL) patients, with early activity also observed in BTK inhibitor-naïve patients, indicating its potential for earlier lines of treatment.
- Good Safety Profile: In a study of 67 patients, tacabrutideg was generally well tolerated with no treatment-related deaths and no new toxicities identified, leading to rapid and sustained improvements in cytopenia, significantly enhancing patients' quality of life.
- Combination Therapy Potential: The combination of BRUKINSA and sonrotoclax showed deep and durable responses in both treatment-naïve and relapsed/refractory settings, particularly in treatment-naïve CLL where a 100% overall response rate and 59.5% complete response rate were achieved, highlighting its potential as a foundation for time-limited therapy.
- Clinical Data Update: Updated data presented at EHA 2026 indicated a 24-month progression-free survival rate of 53.8% for heavily pretreated patients receiving tacabrutideg, providing critical evidence for future clinical applications and potentially transforming the treatment landscape for B-cell malignancies.
See More
BeOne Medicines Stock Shows Oversold Signal
- Oversold Indicator: BeOne Medicines Ltd (Ticker: ONC) hit an RSI of 28.9 during Thursday's trading, indicating an oversold condition with a low price of $253.9475, suggesting that recent heavy selling may be exhausting.
- Market Comparison: Compared to the S&P 500 ETF (SPY) with an RSI of 51.5, ONC's oversold status could attract bullish investors looking for buying opportunities, reflecting a divergence in market sentiment.
- Price Fluctuation: ONC's 52-week low is $239.25 and high is $385.22, with the latest trade at $260.31, indicating potential for price rebound within its trading range.
- Investor Focus: Investors may pay attention to ONC's oversold signal to identify potential buying opportunities, aiming to capitalize on gains when the market rebounds.
See More
BRUKINSA Shows Long-Term Efficacy in Patients Over 80
- Sustained Efficacy: Nearly two-thirds of patients aged 80 and older treated with BRUKINSA remained progression-free after nearly 6.5 years, demonstrating the drug's effectiveness and tolerability in high-risk groups, reinforcing its role as the foundational BTK inhibitor.
- Clinical Data Highlights: The SEQUOIA subgroup analysis revealed a median age of 81 years with a 100% overall response rate and a 72-month progression-free survival rate of 63.8%, indicating BRUKINSA's therapeutic potential in elderly patients, particularly those with high-risk features.
- Safety Analysis: BRUKINSA exhibited consistent safety profiles in long-term follow-ups, particularly in older patients, with low rates of atrial fibrillation enhancing confidence in its use as a first-line treatment, supporting clinical decision-making.
- Patient Decision Factors: Recent studies indicate that safety, disease severity, and efficacy are the primary considerations for patients choosing first-line CLL treatments, while treatment duration is less influential, highlighting the importance of aligning treatment discussions with patient priorities.
See More
BeOne Medicines Presents New Data at ASCO Meeting
- Clinical Data Unveiled: BeOne showcased new data from three priority programs at the 2026 ASCO Annual Meeting, highlighting significant advancements in its oncology pipeline, which are expected to propel multiple assets into pivotal trial phases.
- CDK4 Inhibitor Excels: BGB-43395 demonstrated a confirmed overall response rate of 68.4% in 1L HR+/HER2- metastatic breast cancer, with a favorable safety profile when combined with letrozole, supporting its application in a global randomized Phase 3 clinical trial.
- B7-H4 ADC Shows Promise: BG-C9074 achieved a confirmed overall response rate of 45.5% in ovarian cancer and 40.0% in triple-negative breast cancer, indicating early efficacy across different tumor types and supporting further development efforts.
- GPC3x4-1BB Bispecific Breakthrough: BGB-B2033 exhibited a confirmed overall response rate of 28.9% in heavily pre-treated hepatocellular carcinoma patients, with a favorable safety profile, positioning it for rapid clinical development aimed at establishing a new standard of care in challenging cancers.
See More
BeOne's Drug Shows New Breakthroughs in CLL Treatment
- Long-Term Efficacy Data: The SEQUOIA study indicates that BRUKINSA shows a progression-free survival (PFS) of 71.8% after a median follow-up of 84.01 months, significantly outperforming the 31.0% PFS of the BR group, highlighting its long-term efficacy in first-line treatment for chronic lymphocytic leukemia (CLL).
- Real-World Evidence: An analysis of 10,523 CLL/SLL patients treated with BTK inhibitors revealed that BRUKINSA significantly reduced the risk of death and treatment discontinuation, further solidifying its position as the best-in-class BTK inhibitor.
- Combination Therapy Potential: The combination of BRUKINSA with the next-generation BCL2 inhibitor sonrotoclax demonstrated an unprecedented overall response rate of 100% and a complete response rate of 59.5% in high-risk CLL patients, indicating a promising direction for time-limited treatments.
- Safety Consistency: The safety profile of BRUKINSA remains consistent with previous studies, with no new safety signals identified, ensuring its sustainability and patient confidence in clinical applications.
See More
TEVIMBRA and ZIIHERA Combination Therapy Significantly Improves Survival Rates
- Significant Survival Improvement: The HERIZON-GEA-01 trial demonstrated that the combination of TEVIMBRA and ZIIHERA with chemotherapy achieved a median overall survival of 26.4 months, compared to 19.2 months in the control group, indicating the potential importance of this combination in treating HER2+ gastroesophageal adenocarcinoma.
- Effective Regardless of PD-L1 Status: Results showed that this combination therapy provided significant survival benefits in both PD-L1 positive and negative patients, particularly in those with PD-L1 <1%, where the median survival was 29.7 months, far exceeding the control group's 15.8 months, highlighting its broad applicability.
- Strong Durability of Response: The median duration of response for the ZIIHERA and TEVIMBRA combination was 20.7 months, significantly longer than the 14.3 months for ZIIHERA alone and 8.3 months for the control group, underscoring the clinical significance of this combination in prolonging patient survival.
- Regulatory Progress: The U.S. FDA has accepted a supplemental Biologics License Application for TEVIMBRA with priority review, and the Chinese NMPA has also accepted applications for ZIIHERA and TEVIMBRA, indicating that this combination therapy is poised for rapid approval in multiple markets.
See More
BeOne's Drug Shows Durable Efficacy in Chronic Lymphocytic Leukemia
- Significant Efficacy: Tacabrutideg demonstrated an overall response rate of 85.1% in heavily pretreated relapsed/refractory chronic lymphocytic leukemia (CLL) patients, with early activity also observed in BTK inhibitor-naïve patients, indicating its potential for earlier lines of treatment.
- Good Safety Profile: In a study of 67 patients, tacabrutideg was generally well tolerated with no treatment-related deaths and no new toxicities identified, leading to rapid and sustained improvements in cytopenia, significantly enhancing patients' quality of life.
- Combination Therapy Potential: The combination of BRUKINSA and sonrotoclax showed deep and durable responses in both treatment-naïve and relapsed/refractory settings, particularly in treatment-naïve CLL where a 100% overall response rate and 59.5% complete response rate were achieved, highlighting its potential as a foundation for time-limited therapy.
- Clinical Data Update: Updated data presented at EHA 2026 indicated a 24-month progression-free survival rate of 53.8% for heavily pretreated patients receiving tacabrutideg, providing critical evidence for future clinical applications and potentially transforming the treatment landscape for B-cell malignancies.
See More
BeOne Medicines Stock Shows Oversold Signal
- Oversold Indicator: BeOne Medicines Ltd (Ticker: ONC) hit an RSI of 28.9 during Thursday's trading, indicating an oversold condition with a low price of $253.9475, suggesting that recent heavy selling may be exhausting.
- Market Comparison: Compared to the S&P 500 ETF (SPY) with an RSI of 51.5, ONC's oversold status could attract bullish investors looking for buying opportunities, reflecting a divergence in market sentiment.
- Price Fluctuation: ONC's 52-week low is $239.25 and high is $385.22, with the latest trade at $260.31, indicating potential for price rebound within its trading range.
- Investor Focus: Investors may pay attention to ONC's oversold signal to identify potential buying opportunities, aiming to capitalize on gains when the market rebounds.
See More
BRUKINSA Shows Long-Term Efficacy in Patients Over 80
- Sustained Efficacy: Nearly two-thirds of patients aged 80 and older treated with BRUKINSA remained progression-free after nearly 6.5 years, demonstrating the drug's effectiveness and tolerability in high-risk groups, reinforcing its role as the foundational BTK inhibitor.
- Clinical Data Highlights: The SEQUOIA subgroup analysis revealed a median age of 81 years with a 100% overall response rate and a 72-month progression-free survival rate of 63.8%, indicating BRUKINSA's therapeutic potential in elderly patients, particularly those with high-risk features.
- Safety Analysis: BRUKINSA exhibited consistent safety profiles in long-term follow-ups, particularly in older patients, with low rates of atrial fibrillation enhancing confidence in its use as a first-line treatment, supporting clinical decision-making.
- Patient Decision Factors: Recent studies indicate that safety, disease severity, and efficacy are the primary considerations for patients choosing first-line CLL treatments, while treatment duration is less influential, highlighting the importance of aligning treatment discussions with patient priorities.
See More
BeOne Medicines Presents New Data at ASCO Meeting
- Clinical Data Unveiled: BeOne showcased new data from three priority programs at the 2026 ASCO Annual Meeting, highlighting significant advancements in its oncology pipeline, which are expected to propel multiple assets into pivotal trial phases.
- CDK4 Inhibitor Excels: BGB-43395 demonstrated a confirmed overall response rate of 68.4% in 1L HR+/HER2- metastatic breast cancer, with a favorable safety profile when combined with letrozole, supporting its application in a global randomized Phase 3 clinical trial.
- B7-H4 ADC Shows Promise: BG-C9074 achieved a confirmed overall response rate of 45.5% in ovarian cancer and 40.0% in triple-negative breast cancer, indicating early efficacy across different tumor types and supporting further development efforts.
- GPC3x4-1BB Bispecific Breakthrough: BGB-B2033 exhibited a confirmed overall response rate of 28.9% in heavily pre-treated hepatocellular carcinoma patients, with a favorable safety profile, positioning it for rapid clinical development aimed at establishing a new standard of care in challenging cancers.
See More
BeOne's Drug Shows New Breakthroughs in CLL Treatment
- Long-Term Efficacy Data: The SEQUOIA study indicates that BRUKINSA shows a progression-free survival (PFS) of 71.8% after a median follow-up of 84.01 months, significantly outperforming the 31.0% PFS of the BR group, highlighting its long-term efficacy in first-line treatment for chronic lymphocytic leukemia (CLL).
- Real-World Evidence: An analysis of 10,523 CLL/SLL patients treated with BTK inhibitors revealed that BRUKINSA significantly reduced the risk of death and treatment discontinuation, further solidifying its position as the best-in-class BTK inhibitor.
- Combination Therapy Potential: The combination of BRUKINSA with the next-generation BCL2 inhibitor sonrotoclax demonstrated an unprecedented overall response rate of 100% and a complete response rate of 59.5% in high-risk CLL patients, indicating a promising direction for time-limited treatments.
- Safety Consistency: The safety profile of BRUKINSA remains consistent with previous studies, with no new safety signals identified, ensuring its sustainability and patient confidence in clinical applications.
See More
TEVIMBRA and ZIIHERA Combination Therapy Significantly Improves Survival Rates
- Significant Survival Improvement: The HERIZON-GEA-01 trial demonstrated that the combination of TEVIMBRA and ZIIHERA with chemotherapy achieved a median overall survival of 26.4 months, compared to 19.2 months in the control group, indicating the potential importance of this combination in treating HER2+ gastroesophageal adenocarcinoma.
- Effective Regardless of PD-L1 Status: Results showed that this combination therapy provided significant survival benefits in both PD-L1 positive and negative patients, particularly in those with PD-L1 <1%, where the median survival was 29.7 months, far exceeding the control group's 15.8 months, highlighting its broad applicability.
- Strong Durability of Response: The median duration of response for the ZIIHERA and TEVIMBRA combination was 20.7 months, significantly longer than the 14.3 months for ZIIHERA alone and 8.3 months for the control group, underscoring the clinical significance of this combination in prolonging patient survival.
- Regulatory Progress: The U.S. FDA has accepted a supplemental Biologics License Application for TEVIMBRA with priority review, and the Chinese NMPA has also accepted applications for ZIIHERA and TEVIMBRA, indicating that this combination therapy is poised for rapid approval in multiple markets.
See More
