Hypoalbuminemia

The first treatment of its kind for metastatic NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who progressed on or after a platinum-based regimen Results of the pivotal Phase 3 LUNAR trial represent the first substantial improvement in median overall survival in more than 8 years for this patient population Optune Lua is a wearable treatment that delivers Tumor Treating Fields (TTFields), which exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death ROOT, Switzerland--(BUSINESS WIRE)-- $NVCR --Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen. “Novocure is committed to extending survival in some of the most aggressive and difficult to treat cancers. The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy,” said Asaf Danziger, CEO, Novocure. “We are grateful to the patients, caregivers, investigators and healthcare providers who supported the clinical trials that led to this approval.” Optune Lua is a portable device that produces alternating electric fields known as tumor treating fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death. “There have been a number of important advances in first-line treatment for NSCLC, but this is an aggressive disease, and most patients will develop progression, with limited effective treatment options in second line and beyond,” said Ticiana Leal, MD, Associate Professor and Director of the Thoracic Oncology Program at the Winship Cancer Institute of Emory University School of Medicine and primary investigator of the LUNAR study. “The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than 8 years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease.” “We are excited patients with metastatic NSCLC have more options, which they urgently need,” said GO2 for Lung Cancer Chief Patient Officer Danielle Hicks. “The fight against lung cancer is always evolving, and the number of people affected by this disease is underappreciated. That is why Novocure’s commitment to advancing treatment is exciting for the whole lung cancer community.” Data Supporting the Optune Lua Approval The Phase 3 LUNAR study was a prospective, randomized, open-label, multicenter study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel (experimental arm) to PD-1/PD-L1 inhibitors or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy. The primary endpoint of the study was achieved demonstrating a statistically significant and clinically meaningful 3.3-month (P=0.04) extension in median overall survival (OS) for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n=145). The group treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel had a median OS of 13.2 months (95% CI, 10.3 to 15.5 months) compared to a median OS of 9.9 months (95% CI, 8.2 to 12.2 months) in the PD-1/PD-L1 inhibitor or docetaxel treated group (n=146). The LUNAR study included two pre-specified powered secondary endpoints. The first secondary endpoint, which met statistical significance, assessed median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone. The second secondary endpoint, which showed a positive trend but did not meet statistical significance, assessed Optune Lua concurrently with docetaxel versus docetaxel alone. Patients randomized to Optune Lua and a PD-1/PD-L1 inhibitor (n=70) demonstrated a median OS of 19.0 months (95% CI, 10.6 to 28.2 months) compared to a median OS of 10.8 months (95% CI, 8.3 to 17.6 months) in patients treated a with PD-1/PD-L1 inhibitor alone (n=71), which was a statistically significant extension in median OS of more than 8.0 months (P=0.02). Patients randomized to receive Optune Lua and docetaxel (n=75) had a median OS of 11.1 months (95% CI, 8.2 to 13.9 months) compared to a median OS of 8.9 months (95% CI, 6.5 to 11.3 months) in patients treated with docetaxel alone (n=75). This 2.2 month extension in median OS did not provide a statistically significant demonstrated benefit, but did show a positive trend. Device-related adverse events (AEs) occurred in 63.1% of patients (n=89), these were skin-related disorders under the transducer arrays. The majority of these events were low grade (Grade 1 - 2), with only 4% (n=6) experiencing Grade 3 skin toxicity that required a break from treatment. There were no Grade 4 or Grade 5 toxicities related to Optune Lua, and no device-related AEs that caused death. Baseline patient characteristics were well balanced between cohorts: median age was 65 years (range, 22-86); 66% male, 34% female; 96% of patients had an ECOG performance status of 0-1. PD-L1 expression data were collected from 83% of patients (69 of 83 patients) enrolled at U.S. sites and were well balanced across the four cohorts. Non-Small Cell Lung Cancer (NSCLC) Lung cancer is the most common cause of cancer-related death worldwide 1 , and non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors, including both PD-1 and PD-L1 inhibitors, have been approved for the first-line treatment of NSCLC and the standard of care in this setting continues to evolve rapidly. It is estimated that approximately 30,000 patients actively seek treatment for stage 4 NSCLC after progressing during or after platinum-based therapy each year in the U.S. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors. What is Optune Lua ® approved to treat? Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen. Important Safety Information Who should not use Optune Lua? Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have: An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy. What should I know before using Optune Lua? Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Lua. Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it’s connected If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment What are the possible side effects of Optune Lua? The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing). Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions. About Tumor Treating Fields Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com . About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer. Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter. Forward-Looking Statements In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “could,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. _________________________ 1 World Health Organization Lung Cancer Fact Sheet. Accessed October 3, 2024. , Contacts Investors: Ingrid Goldberg investorinfo@novocure.com Media: Catherine Falcetti media@novocure.com

Updated results with longer follow-up reveal confirmed ORR of 68% and median PFS of 14.2 months in patients with CLDN18.2 high or medium expression, known PD-L1 CPS (n=66). PRINCETON, N.J. and SUZHOU, China, Sept. 18, 2024 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a global clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, today announced the updated results from the cohort-G data for Osemitamab (TST001) plus Nivolumab and CAPOX as the first-line treatment for the patients with advanced G/GEJ cancer (TranStar102). The updated data continues to show encouraging efficacy from previously disclosed data at ASCO 2024. The results showed that in patients with known CLDN18.2 and PD-L1 status, the median progression-free survival (mPFS) reached 14.2 months for those with H/M CLDN18.2 expression, with a confirmed objective response rate of 68%. The vast majority of these patients are PD-L1 CPS<5. Using the group of patients with very low or no CLDN18.2 expression as surrogate control, the HR for the triple combination is 0.505 (95% CI, 0.244-1.045) in favor of the CLDN18.2 H/M, any CPS expressers. The data corroborates the synergistic mechanism of action between CLDN18.2 targeting agent and checkpoint inhibitors reported by Transcenta last year at ESMO which showed that CLDN18.2 targeting antibody can induce PD-L1 expression in gastric cancer tumor cells (even in those with PD-L1 low or null expression) and T-cell infiltration. As of the cutoff date, the median OS was not reached because of the limited number of events, the 12-month survival rate for the overall population (82 patients) in this cohort was 73.8% (95% CI: 62.0- 82.4%). Previous studies have found that the combination of Zolbetuximab+CAPOX in CLDN18.2 positive patients, regardless of the PD-L1 status, leads to an improvement in PFS from 6.80 to 8.21 months (HR = 0.687 (95% CI, 0.544-0.866) (Source: Shah, Manish A et al. Nature Medicine 2023 Aug 29 (8): 2133-2141). This updated Cohort-G data shows that the efficacy from the triple combo therapy of Osemitamab (TST001) plus Nivolumab and CAPOX compares very favorably with the historical data of Nivolumab plus CAPOX combination or Zolbetuximab plus CAPOX combination. The updated data has been featured as a poster presentation (Abstract #1419p) on September 16, 2024 at the ESMO Congress 2024 in Barcelona, Spain. "The updated data from the Cohort-G trial of Osemitamab (TST001) in combination with Nivolumab and CAPOX as first-line treatment for advanced G/GEJ cancer are highly encouraging. The confirmed objective response rate and median progression-free survival in patients with high/medium CLDN18.2 expression, known PD-L1, as compared to patients with no CLDN18.2 expression, confirm the synergy between Osemitamab (TST001) and Checkpoint inhibitors and demonstrates the potential of this triple combination therapy, potentially including in low PD-L1 expressers," said Dr. Caroline Germa, Executive Vice President, Global Medicine Development and Chief Medical Officer at Transcenta, "These results highlight the promise of Osemitamab (TST001) in improving outcomes for patients with advanced G/GEJ cancer." "The Cohort-G data presented at ESMO 2024 provide compelling evidence of the clinical benefit of the triple combination therapy. The significant improvement in progression-free survival and objective response rate, particularly in patients with high/medium CLDN18.2 expression and low PD-L1 CPS, is a testament to the potential of this therapeutic approach," said Professor Lin Shen, Director, department of Gastrointestinal Oncology and Phase I Clinical Trial Center at Peking University Cancer Hospital; and Principal Investigator of the trial, "We are excited about the potential benefits this treatment could bring to our patients." A brief summary of the study is as follows: Study Design Cohort G from Transtar102 study (NCT04495296) was designed to explore the safety and efficacy of Osemitamab (TST001) plus Nivolumab and CAPOX as first-line treatment for advanced G/GEJ cancer, with a safety lead-in and expansion phase. Patients were alternately allocated to 3 or 6mg/ kg at expansion phase. Eligible patients include HER2 negative or unknown, unresectable locally advanced or metastatic G/GEJ cancer, regardless of CLDN18.2 or PD-L1 expression. CLDN18.2 and PD-L1 status were analyzed retrospectively using IHC 14G11 LDT assay and PD-L1 IHC 28-8 pharmDx at a central laboratory. The CLDN18.2 expression was divided into three subgroups: H/ M (high/medium), L (low) and R (rest: lower or negative) according to the tumor cells showing membranous CLDN18.2 staining per CLDN18.2 IHC 14G11 LDT assay. Encouraging ORR and mPFS As of the cut-off date, 82 patients had been dosed with a median follow-up of 15.2 months. The exploratory analysis of the subgroup efficacy of patients in overall, overall with/known CLDN18.2/ PD-L1, and in the subgroup with PD-L1 CPS<5 is as follows: Overall patients group: The mPFS is 12.6 months in patients with high or medium expression (H/M), 7.1 months in patients with low expression (L) and 8.5 months in the rest patients (R). Confirmed ORR was 58.1%, 52.4% and 55.6% respectively. 12 months survival rate for the overall population (n=82) is 73.8%. Overall patients with known CLDN18.2/PD-L1 (n=66): The mPFS is 14.2 months in the patients with high or medium expression (H/M), 8.5 months in patients with low expression (L) and 6.7 months in the rest patients (R). Confirmed ORR was 68.0%, 61.1% and 50.0% respectively. Subgroup with PD-L1 CPS<5 (n=56): The mPFS is 16.6 months in the patients with high or medium expression (H/M), 7.1 months in patients with low expression (L) and 5.7 months in the rest patients (R). Confirmed ORR was 71.4%, 60.0% and 47.1% respectively. Manageable Safety Profile All patients experienced treatment-related adverse events (TRAE). The most common TRAEs were hypoalbuminaemia, nausea and vomiting, most of them were of CTC AE grade 1 or 2 and manageable. The safety profile was similar to TST001 in combination with CAPOX which was presented previously (J Clin Oncol 41, 2023, suppl 16; abstr 4046). About Osemitamab (TST001) Osemitamab (TST001) is a high affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (TranStar101/NCT04396821, TranStar102/NCT04495296). Osemitamab (TST001) has been granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer. About Transcenta Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing. Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. Transcenta is developing 14 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. CONTACT: Bryan Cheng, [email protected], 15067129733 SOURCE Transcenta Holding Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BEIJING--(BUSINESS WIRE)-- Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, announced results from the two presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Details and highlights from the presentations are as follows: Oral Presentation: Title: Efficacy and safety of the Vebreltinib in previously treated, secondary glioblastoma / IDH mutant glioblastoma patients with PTPRZ1-METFUsion GENe (FUGEN): a randomised, multicentre, open-label, phase II/III trial Presenter: Zhaoshi Bao, MD, PhD Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, China Session Title: Central Nervous System Tumors Published Abstract Number: 2003 Isocitrate dehydrogenase (IDH)-mutant gliomas carry a high risk of malignant transformation from low-grade gliomas into high-grade gliomas within 10 years, resulting in poor prognosis. Effective targeted drugs for high-grade gliomas are still lacking. In this open-label, phase II/III trial, 84 patients with histologically confirmed secondary GBM or IDH-mutant GBM were assigned in a 1:1 ratio to receive twice-daily oral vebreltinib at a 300 mg dose or the investigator's choice of chemotherapy (temozolomide [100-150 mg/m2/day, 7 days on followed by 7 days off ]) or cis-platinum [80-100 mg/m2 for 3 days] combined with etoposide [100mg/m2/day for 3 days]) every 28 days. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and objective response rate (ORR). 42 patients of the vebreltinib group and 39 patients of the chemotherapy group were included in the full analysis set. After a median follow-up of 4.44 months, the median OS in the vebreltinib group and chemotherapy group was 6.31 months (95% CI, 4.44-8.77) and 3.38 months (95% CI, 2.37-4.27), respectively. The HR for OS was 0.52 (90% CI, 0.32-0.85; P = 0.009). The median PFS in the vebreltinib group and chemotherapy group was 1.87 months (95% CI, 1.41-2.76) and 1.05 months (95% CI, 0.95-1.77), respectively. The HR for PFS was 0.54 (95% CI, 0.33-0.88; P = 0.014). No significant differences were observed in ORR (9.5% vs. 2.6%) for the vebreltinib group and chemotherapy group. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the vebreltinib group, as compared with 12.2% of those in the chemotherapy group. No treatment-related deaths were observed. These results of the FUGEN trial support the use of vebreltinib as the first target therapy in patients with previously treated, PTPRZ1-MET fusion gene positive, secondary glioblastoma / IDH-mutant glioblastoma, and shed light on a novel therapeutic pathway in the landscape of IDH-mutant high-grade gliomas. "The development of drugs for indications related to MET targets has always been a difficult one. This is not only a victory for translational medicine, but also marks the advent of the era of targeted therapy in the field of brain glioma,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Clinical Trials Information: NCT06105619 and ChiCTR2300077783 Poster Presentation: Title: Efficacy and Safety of Vebreltinib in Patients with Advanced NSCLC Harboring MET Exon 14-Skipping: Results of 2.5-year follow-up in KUNPENG Presenter: Jin-Ji Yang, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China Session Title: Lung Cancer - Non-Small Cell Metastatic Abstract Number: 8557 MET exon 14 skipping mutation is present approximately 3% to 4% of non-small cell lung cancers (NSCLCs) and is associated with poorer survival rates. Vebreltinib (PLB1001), a potent and highly selective c-MET inhibitor, demonstrated superior objective response rate (ORR) benefits in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients (pts) with MET exon 14 (METex14) skipping mutations in the previous analysis of the phase II KUNPENG study. In this Phase II, open-label, multicenter, and multi-cohort study, tumor tissue was assessed for METex14 skipping mutation using next-generation sequencing (NGS) from CAP or CLIA certificated local or central laboratories. Patients in Cohort 1 received 200 mg of vebreltinib twice daily (28 days per cycle) until discontinuation criteria were met. The primary endpoint was ORR assessed by blinded independent review committee (BIRC). Between Jan 17, 2020 and Feb 09, 2021, 52 patients were enrolled in Cohort 1. As of the data cutoff date (Aug 09, 2023), the median duration of follow-up was 19.1 months (range, 1.0-42.7) and the median duration of treatment was 9.9 months (range, 0.6-42.7). Per BIRC assessment, the ORR was 75% (95% CI: 61.1-86.0), the disease control rate (DCR) was 96.2% (95% CI 86.8-99.5), the median duration of response (DoR) was 16.5 months (95% CI 9.2-19.4), the median time to response (TTR) was 1.0 month (95% CI 1.0-2.8), the median progression-free survival (PFS) was 14.3 months (95% CI 6.4-18.2), and the median overall survival (OS) was 20.3 months (95% CI 16.2-29.7). The 3-year OS rate was 35.1%. Subgroup analyses showed the ORR was 100.0%, 66.7%, 85.7% and 100.0% among pts with any baseline brain metastases (N=5), pts with any baseline liver metastases (N=6), pts aged 75 years and older (N=21) and pts with co-occurring of MET amplification (N=12), respectively. The most common (≥20%) treatment-related adverse events (TRAEs) in all of the 135 patients enrolled in this study were peripheral edema (56.3%), hypoalbuminemia (27.4%), hypoproteinemia (25.9%) and anemia (20.7%). "With this study, we continue to see best-in-class potential of Vebreltinib in patients with MET exon 14 skipping mutation NSCLC,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Clinical trial information: NCT04258033 About Avistone Biotechnology Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone) is an innovative biotechnology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and in other solid tumors.