Latest news with #NSCLC
Business Insider
4 hours ago
- Business
- Business Insider
AstraZeneca, Daiichi announce results from three trials on DATROWAY
Results from three trials continue to demonstrate the potential of DATROWAY in combination with various immunotherapies to improve outcomes in patients with non-small cell lung cancer, NSCLC, across multiple stages of the disease. These results from TROPION-Lung02, TROPION-Lung04 and NeoCOAST-2 were presented at the 2025 American Society of Clinical Oncology Annual Meeting. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate, ADC, discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (AZN). In 42 patients receiving first-line doublet DATROWAY plus pembrolizumab, an objective response rate of 54.8% was observed. In 54 patients receiving first-line triplet DATROWAY plus pembrolizumab and platinum chemotherapy, an ORR of 55.6% was observed. This analysis included patients enrolled during the dose escalation phase of the trial, where 4.8% and 40.7% of patients treated with the doublet and triplet regimens, respectively, received DATROWAY at a dose of 4 mg/kg versus 6 mg/kg. First results from cohort 5 of the TROPION-Lung04 phase 1b trial, presented during a poster session on Saturday, May 31, showed DATROWAY plus AstraZeneca's PD-1/TIGIT bispecific antibody rilvegostomig as a first-line treatment demonstrated an ORR of 57.5%, including one complete response and 22 partial responses in 40 patients with advanced or metastatic NSCLC. A disease control rate of 95% was seen. Final results from Arm 4 of the NeoCOAST-2 phase 2 platform trial evaluating neoadjuvant DATROWAY plus AstraZeneca's anti-PD-L1 therapy IMFINZI and single-agent platinum chemotherapy were presented during a poster session on Saturday, May 31 and showed the combination demonstrated a pathologic complete response rate of 35.2%
Associated Press
5 hours ago
- Business
- Associated Press
HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting
— The all-oral chemotherapy-free combination of savolitinib plus osimertinib demonstrated significant PFS benefit with a favorable safety profile in the SACHI Phase III China study — — Webcast to be held at 8:30 am HKT on Tuesday, June 3 to discuss the data presented — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (' HUTCHMED ') (Nasdaq/AIM:HCM; HKEX:13) announces primary results from the interim analysis of the SACHI Phase III study. These results were presented in a late-breaking oral presentation on Sunday, June 1, 2025, during the American Society of Clinical Oncology ('ASCO') Annual Meeting in Chicago, USA. SACHI is a Phase III study of the savolitinib and osimertinib combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR') mutation-positive non-small cell lung cancer ('NSCLC') with MET amplification after disease progression on first-line EGFR inhibitor therapy ( identifier NCT05015608 ). Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI study, said, 'The results from the SACHI Phase III study represent a significant advancement in the treatment of EGFR mutation-positive NSCLC with MET amplification. The savolitinib and osimertinib combination demonstrates promising efficacy in patients who have progressed on prior EGFR inhibitor therapy. These findings highlight the potential of this novel, chemotherapy-free combination to enable a continued oral regimen, offering a convenient and well-tolerated treatment option that addresses critical unmet needs for patients with this challenging disease.' HUTCHMED will host a webcast to discuss the data presented at the ASCO Annual Meeting at 8:30 -9:00 am HKT on Tuesday, June 3, 2025 (8:30 - 9:00 pm EDT on June 2, 2025).The event will be held in English and can be accessed via A replay will also be available on the website shortly after the event. As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival ('PFS') assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy (hazard ratio ['HR'] 0.34; 95% confidence interval ['CI'] 0.23-0.49; p < 0.0001). The independent review committee ('IRC') assessed median PFS was 7.2 months vs 4.2 months, respectively (HR 0.40; 95% CI 0.28-0.59; p < 0.0001). The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively. Overall survival was not mature at the time of the interim analysis. Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor ('TKI')–treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI–naïve populations. In the third generation EGFR-TKI–treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months (HR 0.32; p < 0.0001). The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile. In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Supported by data from SACHI, a New Drug Application (NDA) for the combination of savolitinib and osimertinib for the treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA). About Savolitinib Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. MET is a tyrosine kinase receptor that has an essential role in normal cell development. Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends on the sample type, detection method and assay cut-off used. Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study's inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS
Yahoo
6 hours ago
- Business
- Yahoo
HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting
— The all-oral chemotherapy-free combination of savolitinib plus osimertinib demonstrated significant PFS benefit with a favorable safety profile in the SACHI Phase III China study — — Webcast to be held at 8:30 am HKT on Tuesday, June 3 to discuss the data presented — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM:HCM; HKEX:13) announces primary results from the interim analysis of the SACHI Phase III study. These results were presented in a late-breaking oral presentation on Sunday, June 1, 2025, during the American Society of Clinical Oncology ('ASCO') Annual Meeting in Chicago, USA. SACHI is a Phase III study of the savolitinib and osimertinib combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR') mutation-positive non-small cell lung cancer ('NSCLC') with MET amplification after disease progression on first-line EGFR inhibitor therapy ( identifier NCT05015608). Title: Savolitinib combined with osimertinib versus chemotherapy in EGFR-mutant and MET-amplification advanced NSCLC after disease progression on EGFR tyrosine kinase inhibitor: Results from a randomized Phase III SACHI study Lead Author: Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Session: Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Abstract Number: LBA8505 Date & Time: Sunday, June 1, 2025, 8:00 AM Central Daylight Time Location: Arie Crown Theater Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI study, said, 'The results from the SACHI Phase III study represent a significant advancement in the treatment of EGFR mutation-positive NSCLC with MET amplification. The savolitinib and osimertinib combination demonstrates promising efficacy in patients who have progressed on prior EGFR inhibitor therapy. These findings highlight the potential of this novel, chemotherapy-free combination to enable a continued oral regimen, offering a convenient and well-tolerated treatment option that addresses critical unmet needs for patients with this challenging disease.' The event will be held in English and can be accessed via A replay will also be available on the website shortly after the event. As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival ('PFS') assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy (hazard ratio ['HR'] 0.34; 95% confidence interval ['CI'] 0.23-0.49; p < 0.0001). The independent review committee ('IRC') assessed median PFS was 7.2 months vs 4.2 months, respectively (HR 0.40; 95% CI 0.28-0.59; p < 0.0001). The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively. Overall survival was not mature at the time of the interim analysis. Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor ('TKI')–treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI–naïve populations. In the third generation EGFR-TKI–treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months (HR 0.32; p < 0.0001). The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile. In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Supported by data from SACHI, a New Drug Application (NDA) for the combination of savolitinib and osimertinib for the treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA). About Savolitinib Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. MET is a tyrosine kinase receptor that has an essential role in normal cell development. Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends on the sample type, detection method and assay cut-off used. Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study's inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@ Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@ Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@ Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500
Yahoo
6 hours ago
- Business
- Yahoo
HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting
— The all-oral chemotherapy-free combination of savolitinib plus osimertinib demonstrated significant PFS benefit with a favorable safety profile in the SACHI Phase III China study — — Webcast to be held at 8:30 am HKT on Tuesday, June 3 to discuss the data presented — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM:HCM; HKEX:13) announces primary results from the interim analysis of the SACHI Phase III study. These results were presented in a late-breaking oral presentation on Sunday, June 1, 2025, during the American Society of Clinical Oncology ('ASCO') Annual Meeting in Chicago, USA. SACHI is a Phase III study of the savolitinib and osimertinib combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR') mutation-positive non-small cell lung cancer ('NSCLC') with MET amplification after disease progression on first-line EGFR inhibitor therapy ( identifier NCT05015608). Title: Savolitinib combined with osimertinib versus chemotherapy in EGFR-mutant and MET-amplification advanced NSCLC after disease progression on EGFR tyrosine kinase inhibitor: Results from a randomized Phase III SACHI study Lead Author: Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Session: Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Abstract Number: LBA8505 Date & Time: Sunday, June 1, 2025, 8:00 AM Central Daylight Time Location: Arie Crown Theater Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI study, said, 'The results from the SACHI Phase III study represent a significant advancement in the treatment of EGFR mutation-positive NSCLC with MET amplification. The savolitinib and osimertinib combination demonstrates promising efficacy in patients who have progressed on prior EGFR inhibitor therapy. These findings highlight the potential of this novel, chemotherapy-free combination to enable a continued oral regimen, offering a convenient and well-tolerated treatment option that addresses critical unmet needs for patients with this challenging disease.' The event will be held in English and can be accessed via A replay will also be available on the website shortly after the event. As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival ('PFS') assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy (hazard ratio ['HR'] 0.34; 95% confidence interval ['CI'] 0.23-0.49; p < 0.0001). The independent review committee ('IRC') assessed median PFS was 7.2 months vs 4.2 months, respectively (HR 0.40; 95% CI 0.28-0.59; p < 0.0001). The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively. Overall survival was not mature at the time of the interim analysis. Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor ('TKI')–treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI–naïve populations. In the third generation EGFR-TKI–treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months (HR 0.32; p < 0.0001). The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile. In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Supported by data from SACHI, a New Drug Application (NDA) for the combination of savolitinib and osimertinib for the treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA). About Savolitinib Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. MET is a tyrosine kinase receptor that has an essential role in normal cell development. Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends on the sample type, detection method and assay cut-off used. Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study's inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@ Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@ Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@ Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
10 hours ago
- Business
- Yahoo
Daiichi Sankyo and MSD withdraw US BLA for lung cancer treatment
Daiichi Sankyo and MSD have voluntarily withdrawn the biologics licence application (BLA) in the US for their HER3-directed DXd antibody drug conjugate (ADC) patritumab deruxtecan, intended for treating non-small cell lung cancer (NSCLC). The withdrawal follows discussions with the US Food and Drug Administration (FDA) and topline outcomes from the Phase III trial, HERTHENA-Lung02, which did not meet overall survival (OS) statistical significance. The withdrawal decision was made independently of a complete response letter for the therapy received from the agency in June 2024, relating to an inspection of a third-party manufacturing facility. Discovered by Daiichi Sankyo, the therapy is being co-developed by both companies. The parties have sought approval to treat adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC who have previously undergone two or more systemic treatments. HERTHENA-Lung02 assesses the therapy as a single agent against doublet chemotherapy comprising platinum with pemetrexed induction chemotherapy, followed by pemetrexed maintenance chemotherapy. The safety profile observed in the trial was found to be consistent with prior trials, with no safety concerns. Daiichi Sankyo research and development global head Ken Takeshita said: 'While we are disappointed with the OS results of HERTHENA-Lung02, we are conducting further biomarker analyses to better identify patients that may benefit from patritumab deruxtecan to guide our continued development in lung cancer. 'We remain confident in the broad development programme of this HER3-directed antibody drug conjugate, which currently includes multiple clinical trials across 15 types of cancer.' In October 2023, the companies signed a worldwide partnership to co-develop and commercialise the therapy, along with ifinatamab deruxtecan and raludotatug deruxtecan, with Daiichi Sankyo retaining exclusive rights in Japan. The collaboration expanded in August 2024 to include gocatamig, which will be co-developed and commercialised globally, excluding Japan where MSD holds exclusive rights. "Daiichi Sankyo and MSD withdraw US BLA for lung cancer treatment" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
