On January 14, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that the supplemental New Drug Application for ORPATHYS (savolitinib) has been granted approval by the China National Medical Products Administration ("NMPA") for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alteration (Filing, 6-K, Hutchison China MediTech, JAN 14, 2025, View Source [SID1234649706]). The NMPA has also converted the prior conditional approval of ORPATHYS in the previously treated patient population to full approval. The new label indication for ORPATHYS will now include both treatment-naïve and previously treated patients in China.

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The approval by the NMPA was based on data from the confirmatory Phase IIIb clinical trial in patients with MET exon 14 skipping alteration NSCLC (NCT04923945). Preliminary efficacy and safety data from the first-line cohort were presented during the IASLC World Conference on Lung Cancer (WCLC) in September 2023. Final data from the confirmatory Phase IIIb trial were presented at the European Lung Cancer Congress in March 2024.

In treatment-naïve patients, objective response rate ("ORR") was 62.1%, disease control rate ("DCR") was 92.0% and median duration of response ("DoR") was 12.5 months, as assessed by an independent review committee. Median progression free survival ("PFS") was 13.7 months and median overall survival ("OS") was not reached with median follow-up of 20.8 months. In previously treated patients, ORR was 39.2%, DCR was 92.4% and median DoR was 11.1 months, as assessed by an independent review committee. Median PFS was 11.0 months and median OS was not mature with median follow-up of 12.5 months. Responses occurred early (time to response 1.4-1.6 months) in both treatment-naïve and previously treated patients. The safety profile was tolerable and no new safety signals were observed. The most common drug-related treatment-emergent adverse events of Grade 3 or above (5% or more of patients) were abnormal hepatic function (16.9%), increased alanine aminotransferase (14.5%), increased aspartate aminotransferase (12.0%), peripheral oedema (6.0%) and increased gamma-glutamyltransferase (6.0%).

"This Phase IIIb confirmatory study of ORPATHYS is one of the largest Phase III clinical trials conducted in China for this patient population to date. ORPATHYS has demonstrated clear efficacy and tolerability in both first-line and second-line settings, underscoring its potential as a standard treatment option for NSCLC with MET exon 14 skipping alterations," said 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 confirmatory Phase IIIb study. "By making ORPATHYS available as a first-line treatment, we are able to provide our patients with an effective targeted therapy earlier in their treatment journey. We look forward to introducing this novel treatment and optimizing the treatment strategy for this challenging patient population to improve their outcomes and quality of life."

"The approval marks an exciting step forward in addressing the unmet needs of NSCLC patients with MET exon 14 skipping alteration. It not only validates our research but also emphasizes our dedication to addressing unmet medical needs through targeted drug development," said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. "We are focused on advancing our research and expanding access to ORPATHYS, ultimately improving the treatment landscape for those affected by this challenging form of lung cancer. We also remain committed to further exploring ORPATHYS in other MET driven diseases in order to help more patients who may benefit from this targeted treatment."

"Today’s approval reinforces ORPATHYS as a transformative option for the treatment of biomarker-driven lung cancer, and we are proud that we can now offer this therapy to both first-line and second-line patients in China with advanced NSCLC with MET exon 14 skipping alterations," said Ms. Mary Guan, General Manager of AstraZeneca China Oncology Business. "Through our partnership with HUTCHMED, we are advancing ORPATHYS to address resistance to EGFR-TKIs1, unlocking new possibilities for treating MET-altered and amplified cancers, and expanding the reach of this innovative therapy to even more patients with this form of lung cancer."

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.

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.2 More than a third of the world’s lung cancer patients are in China. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.3 The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and 30-40% of patients in Asia have EGFR-mutated NSCLC.4,5,6,7

MET is a tyrosine kinase receptor that has an essential role in normal cell development.8 MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of acquired resistance to EGFR TKI for metastatic EGFR-mutated NSCLC.8,9 Approximately 2-3% of NSCLC patients have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene.10 MET aberration is a major mechanism for acquired resistance to both first/second-generation EGFR TKIs as well as third-generation EGFR TKIs like osimertinib. Among patients who experience disease progression post-osimertinib treatment, approximately 15-50% present with MET aberration.11,12,13,14,15 The prevalence of MET aberration depends on the sample type, detection method and assay thresholds used.16

About ORPATHYS (savolitinib)

ORPATHYS is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It 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.

ORPATHYS was previously granted conditional approval in China in June 2021 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. ORPATHYS is 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 also currently under clinical development for multiple tumor types, including lung, kidney and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize ORPATHYS. Joint development of ORPATHYS in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of ORPATHYS in China. AstraZeneca is responsible for the commercialization of ORPATHYS in China and worldwide. Sales of ORPATHYS are recognized by AstraZeneca.

On January 14, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the initiation of clinical sites in Germany (Press release, Greenwich LifeSciences, JAN 14, 2025, View Source [SID1234649705]).

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The Company has partnered with GBG (German Breast Group), the largest academic breast cancer research network in Germany, where approximately 38 sites have agreed to participate in FLAMINGO-01. Most of the sites have been approved by German authorities which has led to start-up activity in 2024, and the remaining sites are currently under review.

The GBG Forschungs GmbH, which operates in tandem with the German Breast Group, is renowned as one of the world’s leading breast cancer research organizations. With more than 67,000 study participants and 3,500 new patients per year, GBG is the largest breast cancer study group in Germany, consisting of more than 1,000 doctors in over 800 centers. In 2023, GBG published 64 research articles with a cumulative impact factor of 1,291, showcasing the high quality, cutting-edge research being conducted. More information on GBG can be found at View Source

According to the latest data collected by the European Cancer Information System (click here), a total of 75,267 new cases of breast cancer were diagnosed in Germany in 2022, which is the most common cancer diagnosed in women, representing approximately 29% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Germany with 20,601 deaths in 2022.

Professor Sibylle Loibl, who serves on the FLAMINGO-01 Steering Committee, expressed her excitement about the partnership, stating "We are pleased to collaborate with Greenwich LifeSciences on this important immunotherapy study. With a focus on HER2+ high-risk patients who have not achieved a pathologic complete response (pCR), but also those pCR patients who are having a high-risk of relapse despite achieving a pCR, based on GBG data (von Mackelenbergh 2023), this trial has the potential to further improve our understanding of preventing breast cancer recurrences and improving patient outcomes. We are also very pleased that the first patient from Germany was randomized and treated in October 2024."

Dr. Sibylle Loibl serves as Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH, and Chair of the German Breast Group. She is one of the founding members of GBG. She is well known for her leadership in developing new treatments and organizing large international clinical trials. By 2023, she had written over 1000 original articles, reviews and book chapters and reached an audience of over 13,000 followers in the last year.

Dr. Marcus Schmidt, the national Principal Investigator (PI) for Germany for FLAMINGO-01 and Professor of Molecular Oncology at the University Medical Center Mainz, highlighted the significance of the study in advancing cancer immunotherapy: "The FLAMINGO-01 trial presents a unique opportunity to evaluate GLSI-100’s efficacy in preventing recurrence among HER2-positive breast cancer patients. This trial could pave the way for new treatment paradigms and further the potential of immunotherapies in breast cancer care."

Jaye Thompson, VP of Clinical and Regulatory Affairs, commented, "Adding FLAMINGO-01 sites in Germany will provide access to the largest number of patients in Europe, and GBG has an excellent reputation of providing high quality data. We are fortunate to have a relationship with GBG and the opportunity to offer FLAMINGO-01 to patients in Germany."

Snehal Patel, CEO of Greenwich LifeSciences, added, "Our collaboration with GBG reflects the strength of our mutual commitment to reducing metastatic breast cancer with the latest scientific advancements. By working with one of the world’s leading breast cancer research groups, and with Dr. Loibl’s active participation on our Steering Committee, we are confident that this partnership will accelerate progress and bring life-saving innovations to the forefront."

The GBG clinical sites are listed on clinicaltrials.gov with an interactive map and are shown below.

Augsburg

Hämatologie-Onkologie im Zentrum MVZ

Bayreuth

Klinikum Bayreuth

Berlin

DBZ Onkologie
Helios Klinikum Berlin-Buch GmbH

Bottrop

Marienhospital Bottrop gGmbH

Bremen

Evangelisches Diakonie-Krankenhaus gGmbH

Chemnitz

Klinikum Chemnitz gGmbH

Dessau

Städtisches Klinikum Dessau

Dortmund

St.-Johannes Hospital Dortmund

Dresden

Universitätsklinikum Carl Gustav Carus Dresden

Düsseldorf

MVZ Medical Center Düsseldorf

Eggenfelden

Studienzentrale für das MVZ Eggenfelden e.K.

Essen

Kliniken Essen-Mitte

Frankfurt

Klinikum Frankfurt Höchst

Freiburg

Praxis für interdisziplinäre Onkologie & Hämatologie

Gifhorn

Helios Klinikum Gifhorn

Göttingen

Universitätsmedizin Göttingen

Halle

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale)

Hamburg-Harburg

Gynäkologische Praxisklinik Hamburg Harburg

Hamburg

Mammazentrum Hamburg

Heidelberg

National Center for Tumor Diseases (NCT) Heidelberg

Kassel

Elisabeth-Krankenhaus Kassel

Krefeld

MVZ GynKrefeld GmbH

Langen

Gemeinschaftspraxis für Hämatologie und Onkologie

Leer

MVM Medizinische Verwaltungs- und Managementgesellschaft

Ludwigsburg

RKH Kliniken Ludwigsburg-Bietigheim

Mainz

Universitätsmedizin der Johannes Gutenberg Universität Mainz KöR

Mannheim

Universität Heidelberg

Munich

Klinikum rechts der Isar der TU Muenchen AoeR
München Klinik

Rostock

Klinikum Südstadt Rostock

Rüsselsheim

Gesundheits- und Pflegezentrum Rüsselsheim

Speyer

Diakonissen-Stiftungs-Krankenhaus Speyer (Brustzentrum)

Trier

Klinikum Mutterhaus der Borromäerinnen

Ulm

Universitätsklinikum Ulm

Witten

Marien Hospital Witten

Worms

Klinikum Worms

Wuppertal

Helios Universitätsklinikum Wuppertal

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On January 14, 2025 Eli Lilly and Company (NYSE: LLY) reported that it expects 2024 full-year worldwide revenue to be approximately $45.0 billion, which represents growth of 32% compared to the previous year (Press release, Eli Lilly, JAN 14, 2025, View Source [SID1234649704]). The company also shared 2025 revenue guidance, anticipating sales will be between $58.0 billion and $61.0 billion.

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For Q4 2024, Lilly now expects worldwide revenue to be approximately $13.5 billion, representing growth of 45% compared to Q4 2023. This includes approximately $3.5 billion for Mounjaro and $1.9 billion for Zepbound. In addition to the uptake of Mounjaro and Zepbound, Lilly saw strong performance from its oncology, immunology and neuroscience medicines in Q4 of 2024. In total, non-incretin revenue grew by 20% compared to Q4 2023. However, the company’s expected 2024 revenue is $400 million, or about 3%, below the guidance range issued on October 30, 2024, as part of the Q3 2024 earnings call.

"While the U.S. incretin market grew 45% compared to the same quarter last year, our previous guidance had anticipated even faster acceleration of growth for the quarter. That, in addition to lower-than-expected channel inventory at year-end, contributed to our Q4 results. We continued to make progress on our manufacturing build-out, and U.S. supply across all doses of tirzepatide was available throughout Q4," said David A. Ricks, Lilly chair and CEO. "The rest of our medicines performed within our expectations."

Lilly anticipates revenue growth contributions in 2025 from new Lilly medicines such as Jaypirca, Ebglyss, Omvoh and Kisunla; approvals of new indications for existing Lilly medicines; launches of Mounjaro in additional worldwide markets, as well as potential launches of new medicines such as imlunestrant for metastatic breast cancer. Incretin market and channel dynamics have been factored into the 2025 revenue guidance range.

"2024 was a pivotal and highly successful year for Lilly, and we expect to continue our momentum in 2025 with strong financial and operational performance," continued Ricks. "Sales of Mounjaro and Zepbound posted robust sales growth in Q4, and we expect a continuation of that trend into 2025. We’ll also bring additional manufacturing capacity online and expect to produce at least 60% more salable doses of incretins in the first half of the year compared to the first half of 2024."

As announced previously, Ricks will participate in a fireside chat at the J.P. Morgan Healthcare Conference later today at 5:15 p.m. Eastern time. A live audio webcast of Ricks’ discussion will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 30 days.

The company currently plans to share its full Q4 2024 financial results, including with respect to other metrics included in its financial guidance, and 2025 financial guidance on February 6, 2025.

Preliminary Information
The unaudited financial information presented in this press release is preliminary and may change as a result of, among other factors, Lilly’s financial closing procedures and as a result, the company’s final results may vary materially from the preliminary results included in this press release. The preliminary financial information included in this press release reflects the company’s current estimates based on information available as of the date of this press release and has been prepared by company management. This preliminary information should not be viewed as a substitute for full financial information prepared in accordance with GAAP and is not necessarily indicative of the results to be achieved for any future periods. This preliminary information could be impacted by the effects of financial closing procedures, final adjustments, and other developments.

On January 14, 2025 Crinetics pharmaceutical presented its corporate presentation (Presentation, Crinetics Pharmaceuticals, JAN 14, 2025, View Source [SID1234649703]).

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On January 14, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported its anticipated 2025 milestones as it continues its evolution into becoming a fully integrated biotechnology company focused on orally bioavailable degraders (Press release, C4 Therapeutics, JAN 14, 2025, View Source [SID1234649701]).

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"Stellar execution in 2024 has set up 2025 to be a pivotal year for the company as we work to generate important data that will position us to advance programs and bring degrader medicines to patients searching for new therapeutic options," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "The cemsidomide data presented at the ASH (Free ASH Whitepaper) Annual Meeting in December support a potentially best-in-class profile and we are preparing for the next phase of development of this molecule. We continue to progress the CFT1946 Phase 1/2 study and will leverage data from the tumor specific cohorts to determine the development path for this program. In addition, we expect data from the CFT8919 Phase 1 dose escalation study run by our partner Betta Pharmaceuticals in China, which will define its potential for non-small cell lung cancer patients with the EGFR L858R mutation. We are excited about the degrader rationale for these programs, which we believe have the potential to deliver value for patients, caregivers, physicians and shareholders."

ANTICIPATED 2025 MILESTONES

Cemsidomide: Cemsidomide is an oral degrader of IKZF1/3 for the potential treatment of relapsed/refractory (R/R) multiple myeloma (MM) and R/R non-Hodgkin’s lymphoma (NHL).

Multiple Myeloma

Enable initiation of the next phase of clinical development to investigate cemsidomide in combination with dexamethasone in the late-line setting, and in combination with other MM agents for earlier lines of treatment. These new studies are expected to initiate in early 2026.
Complete Phase 1 dose escalation and present data in the second half of 2025.
Non-Hodgkin’s Lymphoma

Complete Phase 1 dose escalation and present data in the second half of 2025.
Open expansion cohort(s) of the current Phase 1/2 trial in patients with peripheral T-cell lymphoma (PTCL) in the second half of 2025.
Enable initiation of the next phase of clinical development to investigate cemsidomide monotherapy in later lines of therapy in PTCL. This new study is expected to initiate in early 2026.
CFT1946: CFT1946 is an oral degrader targeting BRAF V600 mutations for the potential treatment of solid tumors including colorectal cancer (CRC), melanoma and other malignancies with V600 mutations.

Complete monotherapy Phase 1 dose escalation in BRAF V600 mutant solid tumors in the first half of 2025.
Generate data from the Phase 1 cohorts exploring monotherapy CFT1946 in melanoma, CFT1946 in combination with cetuximab in CRC and CFT1946 in combination with trametinib in melanoma. Data from these cohorts will define and enable the next phase of development.
Present Phase 1 data in the second half of 2025. These presentations will include: (1) monotherapy in BRAF V600 mutant solid tumors, (2) monotherapy expansion cohorts in melanoma, and (3) in combination with cetuximab in CRC.
CFT8919: CFT8919 is an oral degrader targeting EGFR bearing an oncogenic L858R mutation for the potential treatment of non-small cell lung cancer (NSCLC).

Evaluate data from the Phase 1 dose escalation study in Greater China, which is led by partner Betta Pharmaceuticals, in patients with locally or advanced metastatic NSCLC harboring an EGFR L858R mutation. These data will be used to determine the next phase of development.
Discovery: C4T will continue to utilize its TORPEDO platform to develop orally bioavailable degraders for oncology and non-oncology targets for internal research and collaboration programs. To further highlight its deep expertise in drug discovery, C4T plans to:

Present and publish preclinical work from its internal pipeline and TORPEDO platform.
Advance internal and collaboration programs to key milestones.
2024 ACCOMPLISHMENTS

Cemsidomide: C4T advanced the Phase 1/2 clinical trial and delivered data reinforcing the potential of cemsidomide to become a backbone therapy of choice in MM and NHL where IKZF1/3 degradation is warranted.

Multiple Myeloma

At ASH (Free ASH Whitepaper), presented data on cemsidomide in combination with dexamethasone. As of the data cutoff date of October 11, 2024, the dose level exploring 75 µg once daily (QD) achieved an overall response rate (ORR) of 36 percent. Cemsidomide was well-tolerated across all dose levels.
The maximum tolerated dose has not yet been reached. Patients are enrolling in the 100 µg QD cohort.
Non-Hodgkin’s Lymphoma

At ASH (Free ASH Whitepaper), presented data on cemsidomide monotherapy. As of the data cutoff date of October 11, 2024, cemsidomide demonstrated a 38 percent ORR across all subtypes and doses studied. In PTCL, cemsidomide achieved a 44 percent ORR and a 25 percent complete metabolic response rate.
The maximum tolerated dose has not yet been reached. Patients are enrolling in the 75 µg QD cohort.
CFT1946: C4T advanced the Phase 1/2 clinical trial across multiple arms and delivered monotherapy data demonstrating proof of mechanism and early evidence of proof of concept.

At the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, presented monotherapy data demonstrating CFT1946 is well tolerated across all dose levels and demonstrates initial signs of anti-tumor activity across all dose levels.
At the TPD Summit, presented new preclinical data demonstrating CFT1946 has the ability to cross the blood-brain barrier, with Kpu,u values in the range of 0.34 to 0.88.
Progressed the Phase 1 monotherapy dose escalation study. Began enrolling patients across multiple exploratory cohorts: CFT1946 monotherapy in melanoma, CFT1946 in combination with trametinib in melanoma, and CFT1946 in combination with cetuximab in CRC.
CFT8919: Betta Pharmaceuticals, with C4T support, initiated the Phase 1 clinical trial of CFT8919 in Greater China.

Discovery: C4T further validated its TORPEDO platform and advanced key research efforts.

Delivered two development candidates for non-oncology targets to collaborator Biogen.
Established a new collaboration with Merck KGaA, Darmstadt, Germany focused on two critical oncogenic proteins.
Continued to progress its internal discovery portfolio of orally bioavailable degraders.
Corporate: C4T further strengthened its leadership across its management team and Board of Directors to supports its evolution into a fully integrated biotechnology company.

Paige Mahaney, Ph.D., was appointed chief scientific officer. Dr. Mahaney is an experienced drug developer who has helped leading pharmaceutical companies build clinical portfolios across a wide range of disease indications and treatment modalities.
C4T continued to evolve its governance by appointing three new members to its Board of Directors who bring deep experience across drug discovery, commercialization and lifecycle management.
Cash Guidance
C4T expects that its cash, cash equivalents and marketable securities as of December 31, 2024, together with anticipated collaboration expense reimbursements, but excluding any collaboration option or milestone payments, will enable the company to fund its operating plan into 2027.

JP Morgan Presentation
C4T will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 2:15 pm PST (5:15 pm EST). A live webcast will be available under "Events & Presentations" in the Investors section of the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived on the C4T website for at least two weeks following the presentation.