Crizotinib

Long-term pooled data from the pivotal TRUST-I and TRUST-II studies showed similar efficacy, including duration of response and progression-free survival, between CD74 and non-CD74 ROS1 fusion-partner subgroups Among patients who received IBTROZI after prior chemotherapy, response rates remained consistent, offering reassurance for patients who begin chemotherapy before a ROS1 fusion is identified NEW YORK, Sept. 15, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced new subgroup analyses from the pivotal TRUST-I and TRUST-II studies evaluating IBTROZI® (taletrectinib) in both TKI- naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The data, presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, Republic of Korea, demonstrated that IBTROZI delivered consistent efficacy regardless of prior chemotherapy exposure or ROS1 fusion partner, providing additional evidence supporting its use across a broad range of patients with advanced ROS1+ NSCLC. "The most important step for a patient with newly diagnosed non-small cell lung cancer is to conduct comprehensive biomarker testing to identify a targetable driver and start the right targeted therapy as early as possible," said Jorge Nieva, M.D., medical oncologist at USC Norris Comprehensive Cancer Center. "Guidelines recommend holding treatment until biomarker testing comes back, which can create pressure to begin chemotherapy first. These analyses offer reassurance that patients who do start chemotherapy before a ROS1 fusion is identified can still respond well once they transition to taletrectinib. We hope this gives clinicians added confidence to move promptly to targeted therapy as soon as biomarker testing confirms a ROS1 fusion." "We've already been impressed by the durable efficacy of IBTROZI, with many responses lasting over four years, and now these new data answer critical questions about its consistency," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "These analyses show that patients derive a similar, powerful benefit from IBTROZI across multiple subgroups, which we hope gives clinicians even greater confidence in selecting IBTROZI for any patient with advanced ROS1+ NSCLC." Previously at AACR 2026, the pooled analysis of all TKI-naïve patients in the TRUST-I and TRUST-II studies presented showed a confirmed objective response rate (ORR) of 89.8% and a median duration of response (DOR) of 49.7 months. At WCLC, one of the new analyses presented in the poster revealed consistent response rates regardless of prior chemotherapy exposure. Among TKI-naïve patients: ORR was 90.0% in those with prior chemotherapy (n=30) and 89.8% in those with no prior chemotherapy (n=127). Median DOR was 48.3 months and 54.3 months, respectively. While this analysis shows that patients can respond to IBTROZI following prior chemotherapy, treatment guidelines continue to recommend waiting to begin treatment until biomarker results come back and initiating targeted therapy as soon as a ROS1 fusion is confirmed. These findings reinforce the importance of early biomarker testing and prompt transition to targeted therapy. Additionally, both TKI-naïve and TKI-pretreated patients consistently benefited from IBTROZI regardless of ROS1 fusion partner. A fusion partner is the gene that merges with ROS1, resulting in a hybrid, cancer-driving protein that fuels tumor growth. The most common partner is CD74, which accounts for up to half of all ROS1 fusions in NSCLC. Among TKI-naïve patients: ORR was 89.5% in those with CD74 fusions (n=19) and 88.9% in those with non-CD74 fusions (n=18). Median DOR was comparable between the two groups at 44.8 and 43.3 months, respectively, as was median progression-free survival (PFS) at 46.1 and 44.6 months. With long-term follow-up, IBTROZI continued to demonstrate a manageable safety profile consistent with previous reports, with no new safety signals identified. The most common adverse events in the overall TRUST-I and TRUST-II pooled safety analyses were increased AST and ALT, diarrhea, nausea and vomiting, which were mostly low grade. To review the poster, visit the Publications section of Nuvation Bio's website. About ROS1+ NSCLC Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases. About IBTROZI IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1-inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com. About the TRUST Clinical Program The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. U.S. Indication IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc. Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman. ADVERSE REACTIONS Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information . About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the clinical objectives when considering treatment options for advanced ROS1+ NSCLC and IBTROZI'S therapeutic potential. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on August 6, 2026, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. Media and Investor Contacts Nuvation Bio Investor Contact JR DeVita [email protected] Nuvation Bio Media Contact Kaitlyn Nealy [email protected] SOURCE Nuvation Bio Inc. 21% more press release views with Request a Demo

在非小细胞肺癌庞大的突变图谱当中，ROS1融合属于相当小众的一类靶点，大部分普通人对它都没有太深的印象。 从临床统计结果来看，所有确诊非小细胞肺癌的患者里，检出ROS1融合突变的群体仅占到总人数的1%至2%。 这个小众患者群体有着十分鲜明的特征，不少人确诊时年纪尚且不大，并无常年抽烟的习惯。随着病情持续发展，癌细胞向脑部转移的概率会明显走高。 很长一段时间内，临床上可供挑选的治疗手段并不充裕，临床医师以及患者家属，都在等候一款能够打破现有疗效上限的新药登场。 刚刚落下帷幕的2026世界肺癌大会上，一款化学名为zidesamtinib、商品名称Jideytro的新药，对外释放了极具分量的临床研究数据。 未曾接受任何靶向药物干预的初治受试者当中，绝大多数人的肿瘤病灶体积出现明显缩减，还有一部分受试者顺利实现完全缓解，给ROS1突变肺癌开辟了一条全新的治疗路径。 不少读者第一眼看见94%这个数字，难免心生疑惑，如此亮眼的缓解比例放到临床上究竟意味着什么？ 这项代号ARROS‑1的注册临床试验，一共纳入94位晚期非小细胞肺癌受试者。 全部入组受试者均确认ROS1融合阳性，过往没有使用任何TKI类靶向药物开展相关治疗。 历经中位15.2个月的随访监测，经由独立评审委员会统一评估核算，本次试验的客观缓解率最终定格在94%。 用大白话来讲，94名受试者当中一共有88人，肿瘤缩小幅度达到预设标准，并且治疗效果稳定维持了足够久的周期。 更加让人振奋的是，一共有14位受试者达到完全缓解标准，占全部入组人数的15%。 影像复查结果当中已经找不到清晰可辨的肿瘤病灶。 疗效的稳定度同样出彩，96%获得病灶缓解的受试者，疗效维持时长突破12个月。 放眼口服靶向药赛道，一线治疗场景拿到这样一组临床结果，在整个肺癌诊疗领域，已经站到行业第一梯队。 很多人会好奇，这款新药和目前院内常用的老牌靶向制剂相比，二者最核心的差别究竟在哪里？ 现阶段ROS1阳性肺癌一线诊疗阶段，临床医生常会选用克唑替尼、恩曲替尼等药物。 伴随大量真实病例不断沉淀，两款老药身上固有的短板慢慢显露出来。 部分患者连续用药一段时间后会产生耐药突变；还有不少患者的颅内病灶很难管控，脑转移控制效果达不到预期目标。 Jideytro属于新一代ROS1抑制剂，GSK完成对Nuvalent的收购之后，拿到这款药物完整的开发权益。 研发阶段科研人员专门围绕ROS1靶点开展精细化分子层面优化，药物分子和靶点之间结合得更加牢固。 就算患者已经产生多种主流耐药突变，这款新药依旧保有不错的抗肿瘤活性。 早前在后线治疗阶段披露的试验数据同样拥有参考价值。 已经服用其他靶向药并且发生耐药的患者用药后，客观缓解率可达44%； 本身带有可测量脑转移病灶的受试者，颅内病灶缓解比例达到48%。 综合多组试验数据不难看出，这款新药不单单对初次接受治疗的患者起效突出。 就算已经耐药、或是癌细胞转移至脑部的病患，依旧拥有可观的治疗机会。 很多病友最关心的话题：这款新药距离国内普通患者能够正常使用还有多久？ Jideytro已于2026年7月拿到美国FDA审批批件，获批适应症为已经接受过其他方案治疗的ROS1阳性非小细胞肺癌。 本次世界肺癌大会释放的一线临床数据，将支撑GSK在本年度内向FDA提交补充新药申请，争取把用药适应症拓展至一线治疗场景。 倘若一线适应症顺利落地获批，刚刚确诊ROS1阳性肺癌的患者，在治疗起始阶段就能够直接选用这款高缓解率新药。 不必先行使用传统靶向药，等到耐药之后再更换方案。 治疗顺序的调整，有望拉长患者无进展生存周期，降低脑转移持续进展的概率，进一步改善日常生存质量。 回到国内市场来看，这款药品暂时还没有拿到本土上市批文。 不过国内ROS1靶向治疗赛道正在稳步向前推进，后续国内临床试验以及申报审批节奏大概率会持续提速。 哪几类人群需要持续跟踪本次新药相关进展？ 刚刚确诊非小细胞肺癌的病友，尤其是年纪较轻、没有吸烟经历的肺腺癌人群，建议完善基因检测，排查自身是否携带ROS1融合突变。 已经确诊ROS1阳性、当下正在服用第一代靶向药的患者，可以持续留意耐药之后的备选治疗方案。 已经出现脑转移的ROS1阳性病患，可以和主治医生深入沟通，评估个人身体条件是否能够参与适配的临床试验项目。 最近几年，肺癌精准治疗的迭代脚步一直在加快。 行业重心已经从早年“有没有药可以选”，慢慢过渡到“挑选适配度更高的药物”，再进一步向着帮助患者回归正常生活的目标稳步前行。 每一次亮眼临床数据公布的背后，都承载着无数普通家庭的期盼。 互动提问 你觉得国内ROS1靶向新药后续落地的速度会不会继续加快？欢迎大家到评论区聊聊自己的看法。 免责声明 本文仅整理公开医药资讯开展科普解读，不提供诊疗方案参考，也不作为个股以及投资方面的指导意见。文中全部临床数据、药品审批信息，来源于药企官方公告、世界肺癌大会公开材料以及海外医药行业媒体报道。新药研发存在不确定性，海外获批药物的国内上市时间、获批适应症都有可能出现变动。所有治疗方案一定要遵从主治医生的专业判断；投资决策请独立甄别信息，自行承担相关风险。