TEVIMBRA and ZIIHERA Combination Therapy Significantly Improves Survival Rates
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 29 2026
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Should l Buy ONC?
Source: Newsfilter
- Significant Survival Improvement: The global Phase 3 HERIZON-GEA-01 study shows that the combination of TEVIMBRA with ZIIHERA and chemotherapy achieves a median overall survival (OS) of 26.4 months, significantly higher than the control group's 19.2 months, indicating the therapy's potential in treating HER2-positive gastric cancer.
- Clinical Trial Findings: Involving 914 patients, the trial demonstrates that adding TEVIMBRA improves median progression-free survival (PFS) from 8.1 months to 12.4 months, highlighting the combination therapy's critical role in enhancing patient outcomes.
- FDA Priority Review: The U.S. FDA has granted Priority Review and Breakthrough Therapy Designation for the TEVIMBRA and ZIIHERA combination, marking a significant milestone that could expedite market access and provide new treatment options for patients.
- International Collaboration Plan: BeOne intends to participate in the FDA's Project Orbis to accelerate the review of HERIZON-GEA-01 data internationally, aiming to enhance treatment accessibility for HER2-positive gastric cancer patients globally.
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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: 317.000
Low
385.00
Averages
403.76
High
424.00
Current: 317.000
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 Medicines AG Q1 2026 Earnings Call Highlights
- Guidance Upgrade: BeOne Medicines AG raised its 2026 revenue guidance by $100 million, now projecting revenue between $6.3 billion and $6.5 billion, reflecting strong market performance and confidence in future growth.
- Sales Growth: Product revenue reached $1.5 billion in Q1, representing a 34% year-over-year increase, with BRUKINSA sales at $1.1 billion, up 38%, demonstrating the company's leadership position and sustained demand in the BTK market.
- R&D Advancements: The company acquired an exclusive option to license a novel PD-1 VEGF CTLA-4 trispecific antibody, expected to enter clinical trials in June, marking a strategic expansion in the field of tumor immunotherapy.
- Improved Financial Performance: Q1 gross margin improved to 89%, with operating income of $250 million and net income of $227 million, showcasing effective cost control and enhanced profitability measures.
See More
BeiGene Q1 2026 Earnings Exceed Expectations with Strong Revenue Growth
- Strong Performance: BeiGene reported a Q1 2026 non-GAAP EPS of $3.24 and revenue of $1.51 billion, reflecting a 34.8% year-over-year increase, exceeding market expectations by $70 million, indicating robust market performance and profitability.
- Core Product Growth: Global revenues for foundational drug BRUKINSA (zanubrutinib) reached $1.1 billion, up 38% year-over-year, which not only reflects strong market acceptance but also lays a solid foundation for future revenue growth.
- Guidance Adjustment: The company raised its FY 2026 total revenue guidance to $6.3 to $6.5 billion, slightly above the consensus of $6.38 billion, demonstrating management's confidence in future performance and optimistic market demand.
- Operational Efficiency Maintained: GAAP gross margin remains in the high 80% range, with GAAP operating expenses projected between $4.7 to $4.9 billion, indicating the company's ability to control costs while maintaining strong profitability and operational efficiency.
See More
Latest Wall Street Rating Updates
- Apple Rating Reaffirmed: Bernstein raised Apple's price target from $340 to $350, anticipating a 17% revenue growth in FQ2 and a guidance of 14-17% for FQ3, with gross margins at 49.3%, indicating strong market performance and future growth potential.
- KE Holdings Upgrade: Goldman Sachs upgraded KE Holdings from neutral to buy, believing the recent stock price pullback provides an attractive re-entry point for investors, reflecting confidence in the Chinese real estate market.
- Palantir and AMD Downgrade: HSBC downgraded Palantir from buy to hold due to increasing competition; it also downgraded AMD, citing significant stock price appreciation and limited future earnings upside.
- Packaging Corp Upgraded to Buy: Deutsche Bank upgraded Packaging Corp from hold to buy, raising the price target to $256 based on strong Q1 performance and positive management outlook, indicating a pivotal moment for the company in the packaging industry.
See More
TEVIMBRA and ZIIHERA Combination Therapy Significantly Improves Survival Rates
- Significant Survival Improvement: The global Phase 3 HERIZON-GEA-01 study shows that the combination of TEVIMBRA with ZIIHERA and chemotherapy achieves a median overall survival (OS) of 26.4 months, significantly higher than the control group's 19.2 months, indicating the therapy's potential in treating HER2-positive gastric cancer.
- Clinical Trial Findings: Involving 914 patients, the trial demonstrates that adding TEVIMBRA improves median progression-free survival (PFS) from 8.1 months to 12.4 months, highlighting the combination therapy's critical role in enhancing patient outcomes.
- FDA Priority Review: The U.S. FDA has granted Priority Review and Breakthrough Therapy Designation for the TEVIMBRA and ZIIHERA combination, marking a significant milestone that could expedite market access and provide new treatment options for patients.
- International Collaboration Plan: BeOne intends to participate in the FDA's Project Orbis to accelerate the review of HERIZON-GEA-01 data internationally, aiming to enhance treatment accessibility for HER2-positive gastric cancer patients globally.
See More
BeiGene to Announce Q1 Earnings on April 15
- Earnings Announcement Schedule: BeiGene is set to release its Q1 2023 earnings report on April 15 after market close, with consensus estimates predicting an EPS of $0.85 and revenue of $1.45 billion, indicating a stable performance in the market.
- Performance Exceeding Expectations: Over the past year, BeiGene has beaten EPS estimates 100% of the time and revenue estimates 75% of the time, showcasing the company's strong capabilities in profitability and market expectation management.
- Expectation Revision Dynamics: In the last three months, EPS estimates have seen two upward revisions and one downward revision, while revenue estimates have experienced two upward and two downward revisions, reflecting a cautiously optimistic market outlook on the company's future performance.
- Market Environment Impact: Amid disruptions in the Middle East, over $10 billion worth of healthcare stocks on Wall Street are considered oversold, and as a participant in the industry, BeiGene may be affected by fluctuations in market sentiment.
See More
BeOne Medicines Receives Conditional Approval for Lung Cancer Treatment in China
- Drug Approval: BeOne Medicines announced that its bispecific T-cell engager tarlatamab, developed in partnership with Amgen, received conditional approval in China as a second-line treatment for extensive-stage small cell lung cancer, marking a significant milestone for the company in the Chinese market.
- Market Potential: Approximately 160,000 patients are diagnosed with small cell lung cancer in China each year, accounting for nearly 15% of global lung cancer cases, providing a substantial market opportunity for tarlatamab, especially given the limited efficacy of existing treatments.
- Treatment Need: Despite platinum-based chemotherapy being the main first-line therapy, the majority of small cell lung cancer patients experience disease progression within six months, thus the approval of tarlatamab offers a new treatment option that could potentially improve survival rates and quality of life for these patients.
- Collaboration Background: BeOne Medicines has been developing tarlatamab in Mainland China under a licensing agreement with Amgen since 2019, and this approval not only strengthens the partnership between the two companies but also lays a foundation for BeOne's further development in the biopharmaceutical sector.
See More
BeOne Medicines AG Q1 2026 Earnings Call Highlights
- Guidance Upgrade: BeOne Medicines AG raised its 2026 revenue guidance by $100 million, now projecting revenue between $6.3 billion and $6.5 billion, reflecting strong market performance and confidence in future growth.
- Sales Growth: Product revenue reached $1.5 billion in Q1, representing a 34% year-over-year increase, with BRUKINSA sales at $1.1 billion, up 38%, demonstrating the company's leadership position and sustained demand in the BTK market.
- R&D Advancements: The company acquired an exclusive option to license a novel PD-1 VEGF CTLA-4 trispecific antibody, expected to enter clinical trials in June, marking a strategic expansion in the field of tumor immunotherapy.
- Improved Financial Performance: Q1 gross margin improved to 89%, with operating income of $250 million and net income of $227 million, showcasing effective cost control and enhanced profitability measures.
See More
BeiGene Q1 2026 Earnings Exceed Expectations with Strong Revenue Growth
- Strong Performance: BeiGene reported a Q1 2026 non-GAAP EPS of $3.24 and revenue of $1.51 billion, reflecting a 34.8% year-over-year increase, exceeding market expectations by $70 million, indicating robust market performance and profitability.
- Core Product Growth: Global revenues for foundational drug BRUKINSA (zanubrutinib) reached $1.1 billion, up 38% year-over-year, which not only reflects strong market acceptance but also lays a solid foundation for future revenue growth.
- Guidance Adjustment: The company raised its FY 2026 total revenue guidance to $6.3 to $6.5 billion, slightly above the consensus of $6.38 billion, demonstrating management's confidence in future performance and optimistic market demand.
- Operational Efficiency Maintained: GAAP gross margin remains in the high 80% range, with GAAP operating expenses projected between $4.7 to $4.9 billion, indicating the company's ability to control costs while maintaining strong profitability and operational efficiency.
See More
Latest Wall Street Rating Updates
- Apple Rating Reaffirmed: Bernstein raised Apple's price target from $340 to $350, anticipating a 17% revenue growth in FQ2 and a guidance of 14-17% for FQ3, with gross margins at 49.3%, indicating strong market performance and future growth potential.
- KE Holdings Upgrade: Goldman Sachs upgraded KE Holdings from neutral to buy, believing the recent stock price pullback provides an attractive re-entry point for investors, reflecting confidence in the Chinese real estate market.
- Palantir and AMD Downgrade: HSBC downgraded Palantir from buy to hold due to increasing competition; it also downgraded AMD, citing significant stock price appreciation and limited future earnings upside.
- Packaging Corp Upgraded to Buy: Deutsche Bank upgraded Packaging Corp from hold to buy, raising the price target to $256 based on strong Q1 performance and positive management outlook, indicating a pivotal moment for the company in the packaging industry.
See More
TEVIMBRA and ZIIHERA Combination Therapy Significantly Improves Survival Rates
- Significant Survival Improvement: The global Phase 3 HERIZON-GEA-01 study shows that the combination of TEVIMBRA with ZIIHERA and chemotherapy achieves a median overall survival (OS) of 26.4 months, significantly higher than the control group's 19.2 months, indicating the therapy's potential in treating HER2-positive gastric cancer.
- Clinical Trial Findings: Involving 914 patients, the trial demonstrates that adding TEVIMBRA improves median progression-free survival (PFS) from 8.1 months to 12.4 months, highlighting the combination therapy's critical role in enhancing patient outcomes.
- FDA Priority Review: The U.S. FDA has granted Priority Review and Breakthrough Therapy Designation for the TEVIMBRA and ZIIHERA combination, marking a significant milestone that could expedite market access and provide new treatment options for patients.
- International Collaboration Plan: BeOne intends to participate in the FDA's Project Orbis to accelerate the review of HERIZON-GEA-01 data internationally, aiming to enhance treatment accessibility for HER2-positive gastric cancer patients globally.
See More
BeiGene to Announce Q1 Earnings on April 15
- Earnings Announcement Schedule: BeiGene is set to release its Q1 2023 earnings report on April 15 after market close, with consensus estimates predicting an EPS of $0.85 and revenue of $1.45 billion, indicating a stable performance in the market.
- Performance Exceeding Expectations: Over the past year, BeiGene has beaten EPS estimates 100% of the time and revenue estimates 75% of the time, showcasing the company's strong capabilities in profitability and market expectation management.
- Expectation Revision Dynamics: In the last three months, EPS estimates have seen two upward revisions and one downward revision, while revenue estimates have experienced two upward and two downward revisions, reflecting a cautiously optimistic market outlook on the company's future performance.
- Market Environment Impact: Amid disruptions in the Middle East, over $10 billion worth of healthcare stocks on Wall Street are considered oversold, and as a participant in the industry, BeiGene may be affected by fluctuations in market sentiment.
See More
BeOne Medicines Receives Conditional Approval for Lung Cancer Treatment in China
- Drug Approval: BeOne Medicines announced that its bispecific T-cell engager tarlatamab, developed in partnership with Amgen, received conditional approval in China as a second-line treatment for extensive-stage small cell lung cancer, marking a significant milestone for the company in the Chinese market.
- Market Potential: Approximately 160,000 patients are diagnosed with small cell lung cancer in China each year, accounting for nearly 15% of global lung cancer cases, providing a substantial market opportunity for tarlatamab, especially given the limited efficacy of existing treatments.
- Treatment Need: Despite platinum-based chemotherapy being the main first-line therapy, the majority of small cell lung cancer patients experience disease progression within six months, thus the approval of tarlatamab offers a new treatment option that could potentially improve survival rates and quality of life for these patients.
- Collaboration Background: BeOne Medicines has been developing tarlatamab in Mainland China under a licensing agreement with Amgen since 2019, and this approval not only strengthens the partnership between the two companies but also lays a foundation for BeOne's further development in the biopharmaceutical sector.
See More
