Savolitinib

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

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Friday, April 5, 2024
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HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
  • Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia.
  • Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models.
  • Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo.

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

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Thursday, March 28, 2024
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HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.

Key Points: 
  • Savolitinib was previously granted conditional approval in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
  • Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
  • More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.
  • The data from this study provide confirmatory evidence for savolitinib as a targeted treatment option for treatment-naïve or previously treated patients with MET exon 14 skipping alteration NSCLC.

Phanes Therapeutics Announces the Appointment of Internationally Renowned Oncologist Prof. Shun Lu to its Clinical Advisory Board

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Thursday, September 14, 2023
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SAN DIEGO, Sept. 14, 2023 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, today announced that Professor Shun Lu, an internationally renowned oncologist and professor at Shanghai Jiao Tong University Chest Hospital, has joined the Company's Clinical Advisory Board (CAB).

Key Points: 
  • SAN DIEGO, Sept. 14, 2023 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, today announced that Professor Shun Lu, an internationally renowned oncologist and professor at Shanghai Jiao Tong University Chest Hospital, has joined the Company's Clinical Advisory Board (CAB).
  • "We are excited to have Professor Lu joining our Clinical Advisory Board," said Rita Laeufle, MD, PhD, Phanes' Chief Medical Officer. "
  • Professor Lu is a leading clinician-scientist in the field of lung cancer.
  • He also served on the International Affairs Committee (IAC) of American Clinical Oncology Society (2008-2011) and MCMC Working Group (2008-2016).

HUTCHMED Highlights Presentation of Results from the Phase IIIb Trial of Savolitinib at the 2023 World Conference of Lung Cancer

Retrieved on: 
Tuesday, September 12, 2023
Neoplasm, DCR, NSCLC, AstraZeneca, Dor, Patient, Savolitinib, Confidence interval, MET, NMPA, ORR, Safety, Pharmaceutical industry

At median follow-up of 11.1 months, median progression free survival (mPFS) was 13.8 months (95% CI: 9.7 months to not reached).

Key Points: 
  • At median follow-up of 11.1 months, median progression free survival (mPFS) was 13.8 months (95% CI: 9.7 months to not reached).
  • The other cohort of this confirmatory trial was fully enrolled in H1 2023 and included patients who received prior treatments.
  • The trial follows the June 2021 approval of savolitinib as a monotherapy in this indication from China’s National Medical Products Administration (NMPA), which was based on positive results from a Phase II trial ( NCT02897479 ).
  • This confirmatory trial enrolled a more representative proportion of the different NSCLC subtypes, which may confer different prognostic outcomes.

HUTCHMED Initiates Registration Phase Enrollments of HMPL-453 for IHCC and Savolitinib for Gastric Cancer following NMPA Consultations

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Tuesday, April 4, 2023
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If positive, the data from the registration phase may be used to support a future New Drug Application (“NDA”) filing.

Key Points: 
  • If positive, the data from the registration phase may be used to support a future New Drug Application (“NDA”) filing.
  • In addition, it also reached an agreement to initiate the registration phase of the ongoing Phase II trial of savolitinib for gastric cancer patients with mesenchymal–epithelial transition (“MET”) amplification following NMPA consultation.
  • If positive, the data from the registration phase may be used to support a future NDA filing.
  • The study of savolitinib is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer and esophagogastric junction adenocarcinoma patients with MET amplification.

HUTCHMED Announces Agreement with NHSA for Inclusion of ORPATHYS® in the National Reimbursement Drug List in China

Retrieved on: 
Wednesday, January 18, 2023
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The updated NRDL will take effect from March 1, 2023.

Key Points: 
  • The updated NRDL will take effect from March 1, 2023.
  • Savolitinib, marketed in China under the brand name ORPATHYS®, is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) jointly developed by AstraZeneca and HUTCHMED with HUTCHMED taking the lead in China, and commercialized by AstraZeneca worldwide.
  • Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: “The NRDL has significantly broadened access to novel medicines for Chinese patients.
  • We are gratified to see that our third novel oncology medicine, ORPATHYS®, will be included in this year’s NRDL update.

TAGRISSO® plus savolitinib demonstrated 49% objective response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial

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Monday, August 8, 2022
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The global SAFFRON Phase III trial will further assess the TAGRISSO plus savolitinib combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following TAGRISSO.

Key Points: 
  • The global SAFFRON Phase III trial will further assess the TAGRISSO plus savolitinib combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following TAGRISSO.
  • In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases 10% from baseline and a drop to
  • For symptomatic congestive heart failure, permanently discontinue TAGRISSO
    Keratitis was reported in 0.7% of 1479 patients treated with TAGRISSO in clinical trials.
  • Beyond epidermal growth factor receptor: MET amplification as a general resistance driver to targeted therapy in oncogene-driven non-small-cell lung cancer.

HUTCHMED Highlights First Presentation of Results of the SAVANNAH Global Phase II Trial of Savolitinib plus TAGRISSO® at the 2022 WCLC Annual Meeting

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Wednesday, July 13, 2022
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In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib.

Key Points: 
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib.
  • Joint development of savolitinib in China is led by HUTCHMED, while AstraZeneca leads development outside of China.
  • Based on results of the TATTON and SAVANNAH studies below, several Phase III studies of savolitinib in combination with TAGRISSO have been initiated, including SACHI, SANOVO and SAFFRON.
  • This trial follows multiple Phase II studies that have been conducted in Asia to study savolitinib in MET-driven GC patients, including VIKTORY25.

HUTCHMED Receives a US$15 million Milestone from AstraZeneca for Initiating Start-up Activities for a Global Phase III Study of ORPATHYS® in Lung Cancer

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Monday, March 7, 2022
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To date, AstraZeneca has now paid HUTCHMED US$85 million of the total US$140 million in upfront payments, development and first-sale milestones due under the license and collaboration agreement between HUTCHMED and AstraZeneca.

Key Points: 
  • To date, AstraZeneca has now paid HUTCHMED US$85 million of the total US$140 million in upfront payments, development and first-sale milestones due under the license and collaboration agreement between HUTCHMED and AstraZeneca.
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib.
  • Under the current terms of the agreement, a US$15 million milestone payment is triggered by the initiation of start-up activities for the SAFFRON study.
  • Joint development of savolitinib in China is led by HUTCHMED, while AstraZeneca leads development outside of China.

HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors

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Monday, September 20, 2021
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HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 19, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors (NETs).

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 19, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors (NETs).
  • This Japan study is a two-stage, open label study of surufatinib where approximately 34 patients are expected to be recruited.
  • In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR).
  • Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan.