Sunitinib Malate

Three Registration-Directed Top-line Data Readouts Remain on Track in 2025: SUMMIT in NonAdvanced SM expected in July, APEX in Advanced SM expected in second half of the-year and PEAK in GIST expected by end of year Ended 1Q 2025 with $245.7 million in cash, sufficient to fund operations into late 2026 WALTHAM, Mass. and BOULDER, Colo., May 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 was very productive for Cogent as our team focused on executing across our portfolio in preparation for three transformative data readouts this year. We look forward to reporting top-line results from our registration-directed SUMMIT trial with bezuclastinib in patients with nonadvanced systemic mastocytosis in July, followed later in the year with top-line results from our APEX and PEAK trials,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “While we are preparing for a potential launch of bezuclastinib in 2026, we are also very proud of the progress we have made with our early-stage pipeline, including presentations from four distinct programs recently at the annual AACR conference.” Recent Business Highlights Announced expanded clinical results from the Open Label Extension (OLE) portion of the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting. Bezuclastinib showed a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, including 88% of patients achieving at least a 50% reduction in TSS. The safety profile for bezuclastinib remains favorable, with adverse events reported primarily as low-grade and reversible. No treatment-related bleeding or cognitive impairment was observed. The most common treatment-related adverse events were hair discoloration and transient elevations in liver transaminases. All cases of elevated transaminases were asymptomatic and fully reversible. Presented updated preclinical data from the company’s KRAS, PI3Kα, FGFR2/3 and ErbB2 candidates at the American Association of Cancer Research (AACR) annual meeting. Bezuclastinib showed a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, including 88% of patients achieving at least a 50% reduction in TSS. The safety profile for bezuclastinib remains favorable, with adverse events reported primarily as low-grade and reversible. No treatment-related bleeding or cognitive impairment was observed. The most common treatment-related adverse events were hair discoloration and transient elevations in liver transaminases. All cases of elevated transaminases were asymptomatic and fully reversible. Upcoming Milestones Announce top-line results from SUMMIT in July 2025. SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with NonAdvSM. Announce top-line results from APEX in the second half of 2025. APEX is a registration-directed, global, open-label trial in patients with advanced systemic mastocytosis (AdvSM). Announce top-line results from PEAK by the end of 2025. PEAK is a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST). First Quarter 2025 Financial Results Cash and Cash Equivalents: As of March 31, 2025, cash, cash equivalents and marketable securities were $245.7 million. During the quarter, the Company sold shares under the Company’s at-the-market (ATM) stock offering for net proceeds of $24.3 million and incurred a non-recurring payment of $9.6 million related to annual performance-based bonus compensation. Based on its current plans, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into late 2026, including through clinical readouts from ongoing SUMMIT, PEAK, and APEX registration-directed trials. R&D Expenses: Research and development expenses were $63.0 million for the first quarter of 2025 compared to $52.7 million for the first quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.3 million for the first quarter of 2025 as compared to $4.4 million for the first quarter of 2024. G&A Expenses: General and administrative expenses were $11.9 million for the first quarter of 2025 compared to $9.7 million for the first quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $4.8 million for the first quarter of 2025 as compared to $5.0 million for the first quarter of 2024. Net Loss: Net loss was $72.0 million for the first quarter of 2025 compared to a net loss of $58.3 million for the first quarter of 2024. About Cogent Biosciences, Inc.Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the expectation to report SUMMIT top-line results in July 2025; the expectation to report APEX top-line results in the second half of 2025; the expectation to report PEAK top-line results by the end of 2025; the company’s anticipated cash runway into late 2026; and the potential commercial launch of bezuclastinib in 2026. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact:Christi WaarichSenior Director, Investor Relationschristi.waarich@cogentbio.com617-830-1653

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ELCC 2025 微专辑扫描二维码可查看更多内容在2025年欧洲肺癌大会（ELCC）上，巴黎居里研究所肿瘤内科主任Nicolas Girard教授重磅发布SOHO-01和COCOON试验数据，并作题为"胸腺上皮肿瘤全身治疗最新进展"的专题报告。应《肿瘤瞭望》邀请，Girard教授对SOHO-01和COCOON研究结果以及胸腺上皮肿瘤治疗进展进行了深度解读。您在2025 ELCC报告了I/II期SOHO-01研究的两个扩展队列的结果（摘要3O）。请谈谈BAY 2927088对既往接受过治疗HER2突变型非小细胞肺癌（NSCLC）患者的安全性和有效性。Dr. Girard：HER2突变型NSCLC是NSCLC的一小部分，占2-4%。BAY 2927088是一种口服酪氨酸激酶抑制剂，可以抑制HER2。SOHO-01研究评估了BAY 2927088在HER2突变型NSCLC患者中的疗效。在剂量扩展阶段采用每日两次，每次20 mg的剂量。我在2025年ELCC大会上展示了两组患者的研究结果。第一组患者是未接受过HER2靶向治疗但之前接受过全身治疗的患者（n=44）；第二组患者是之前接受过HER2靶向抗体药物偶联物（ADC）治疗的患者（n=34）。第一组患者中，研究者评估的客观缓解率（ORR）高达70.5%，疾病控制率（DCR）为81.8%，中位缓解持续时间（DOR）长达8.7个月，意味着患者在接受化疗±免疫治疗后，BAY 2927088疗法仍具有很高的疗效。第二组患者中（超过一半的患者之前接受过≥三线治疗），ORR为35.3%，DCR为52.9%，中位DOR为9.5个月，在接受化疗、免疫检查点抑制剂和ADC治疗后别无选择的情况下，这个数字相当高。BAY 2927088的安全性主要体现在腹泻（1/2级），目前没有患者因腹泻而停药。腹泻是最常见的副作用，我们可能需要对腹泻进行预防性治疗。我们正在进行一项III期临床试验SOHO-02，该试验旨在对比HER2突变型NSCLC患者接受一线BAY 2927088和化疗+免疫治疗。（上下滑动可查看）Dr. Girard: I am Nicolas Girard. I am Head of Medical Oncology at Institut Curie in Paris.HER2 NSCLC is a small subset of NSCLC, 2-4%. We have BAY 2927088 (BAY 88), which is an oral tyrosine kinase inhibitor that is inhibiting HER2. The SOHO-01 study assessed this compound in patients with EGFR HER2-mutated NSCLC. After dose expansions, dosing of 20mg twice daily was chosen for expansion. At ELCC 2025, I presented the results of two cohorts. The first one being a cohort of patients who were HER2-targeted therapy naïve, but who had previously received systemic therapy, The second was patients who had received prior treatment with HER2-targeting antibody-drug conjugates. Forty-four patients and 34 patients were treated respectively. What we see from the SOHO-01 trial is a high response rate in HER2-targeted treatment naïve patients – 72%, which is quite high. There was a duration of efficacy of 9 months in this cohort of patients is quite long. It means that after treatment with chemotherapy plus or minus immunotherapy, BAY 88 has a high efficacy. The second cohort were previously treated patients with three or more lines of therapy in more than half the patients. We see a response rate of 35% and a control rate of 53%. This is quite high in the setting of having no more option after treatment with chemotherapy, IO and ADCs. The safety of BAY 88 was mostly diarrhea (grade 1/2), with no discontinuation due to diarrhea. We probably need to implement prophylactic management for diarrhea, which was the most frequent side effect. We have an ongoing phase III trial, SOHO-02, in the first-line setting, versus chemotherapy and immunotherapy for patients with EGFR-mutated NSCLC.根据您在2025 ELCC汇报的COCOON试验结果（摘要10MO），对于接受埃万妥单抗联合兰泽替尼治疗的EGFR突变型晚期NSCLC患者，如何预防中度至重度皮肤不良事件？Dr. Girard：COCOON试验的主要目的是评估预防性治疗能否降低EGFR突变型局部晚期/转移性NSCLC患者接受埃万妥单抗+兰泽替尼治疗前12周出现的≥2级皮肤病副作用。EGFR突变NSCLC的标准治疗方案是奥希替尼，在中国和亚洲还有其他第三代TKI可选。随着MARIPOSA研究证明埃万妥单抗联合兰泽替尼相比奥希替尼显著改善总生存期（两组中位总生存差异超过1年），该疗法将成为此类患者一线治疗的新标准。然而，埃万妥单抗联合兰泽替尼的皮肤不良反应发生率较高，尤其是在治疗的前四个月。COCOON研究评估了预防性皮肤病治疗（口服多西环素或米诺环素12周，随后头皮涂抹克林霉素乳液；指甲涂抹氯己定手液；身体和面部涂抹神经酰胺保湿霜）与标准治疗相比，能否改善埃万妥单抗+兰泽替尼的皮肤毒性。在中位随访期约4个月早期时间点进行的首次中期分析中，预防性方案带来获益，前12周≥2级皮肤不良事件（AE）（76.5% vs. 38.6%）和3级皮肤AE（8.8% vs. 4.3%）发生率仅为标准治疗组的50%，因不良事件导致的停药率降低了50%。显然，根据MARIPOSA试验进行埃万妥单抗联合兰泽替尼治疗时，必须同时采用COCOON预防性方案，同时配合静脉血栓栓塞症（VTE）预防以及输液相关反应的预防。（上下滑动可查看）Dr. Girard: The COCOON trial had the objective of assessing whether prophylactic dermatologic management could prevent Grade 2 or higher dermatological side effects that are associated with the administration of amivantamab plus lazertinib in patients with EGFR-mutated NSCLC. For EGFR-mutated NSCLC, the historic standard-of-care is osimertinib, and there are other third-generation TKIs available in China and Asia. Amivantamab plus lazertinib demonstrate an overall survival benefit versus osimertinib. This is a significant benefit with > 1 year difference in median overall survival. So, it is a new standard-of-care for first-line treatment in these patients. But this combination has been associated with high rates of dermatologic adverse effects, especially in the first four months. COCOON assessed whether prophylactic dermatologic management versus standard-of-care could improve this situation. COCOON is doxycycline, clindamycin lotion, chlorhexidine wash for hands and feet, and a ceramide-based moisturizer on the body and face. At the first interim analysis at the early timepoint of four months median follow-up, we see a benefit with COCOON regimen from 77% of patients presenting with Grade 2 or higher dermatologic adverse events after 12 weeks of follow-up to 40% of patients. So, it is a two-fold decrease in the incidence of dermatological adverse events – a two-fold decrease in Grade 3 events, a two-fold decrease in dose modification of amivantamab plus lazertinib. Clearly, this goes with MARIPOSA with amivantamab and lazertinib. COCOON has to be implemented as part of this treatment together with along with venous thromboembolism (VTE) prophylaxis, and prophylaxis for infusion-related reactions.您在2025 ELCC汇报了“胸腺上皮肿瘤全身治疗的最新进展”，请分享这项报告的主要内容。Dr. Girard：晚期或转移性胸腺上皮肿瘤领域近期取得多项进展。在一线治疗中，除了历史悠久的细胞毒性化疗外，一些临床试验探索了新方案，例如化疗（卡铂-紫杉醇）联合抗血管生成药物（包括雷莫芦单抗和贝伐珠单抗）。近期研究显示，化疗联合抗血管生成药物的三联方案（卡铂+紫杉醇+雷莫芦单抗）可显著延长无进展生存期（相比传统化疗的数据），可能成为这类患者的优选方案。当前治疗模式正从单纯化疗向“化疗+抗血管生成药物±免疫疗法”转变。二线治疗选择包括化疗药物、抗血管生成药物（例如舒尼替尼和仑伐替尼）以及免疫检查点抑制剂（单药或联合抗血管生成药物）。同样，联合策略和用药顺序正在发生变化。好消息是，胸腺上皮肿瘤的治疗有了更多选择。（上下滑动可查看）Dr Girard: A lot is coming in thymic epithelial tumors. We have the historic cytotoxic chemotherapy regimens for the first-line treatment of patients with advanced metastatic thymic tumors. We have some new trials combining chemotherapy (carboplatin-paclitaxel) with antiangiogenic agents, including ramucirumab, and bevacizumab. This may be one option for those patients. We have also seen data with combination of chemotherapy plus antiangiogenic agents, a triad of carboplatin plus paclitaxel plus ramucirumab, reporting quite prolonged progression-free survival, which is probably the best endpoint in these patients. There is movement away from chemotherapy alone to combinations of chemotherapy plus antiangiogenic agents plus immunotherapy. In the second-line setting, we have chemotherapy, we have antiangiogenic agents, sunitinib for thymoma, lenvatinib for thymic carcinoma, immune checkpoint inhibitors as single agent or combined with antiangiogenic agents. Again, the combinations and sequence are moving. What is good is that we have more options for the management of those patients.《肿瘤瞭望》在ELCC现场报道（来源：《肿瘤瞭望》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。