Lazertinib

Total Revenue Increased 34% YOY to $290 million and Royalty Revenue Increased 36% YOY to $155 million Net Income Increased 67% YOY to $137 million and Adjusted EBITDA Increased 60% YOY to $184 million GAAP Diluted EPS Increased 72% YOY to $1.05 and Non-GAAP Diluted EPS Increased 69% YOY to $1.271 Raised 2024 Financial Guidance Ranges for Total Revenue of $970-$1,020 million, Representing YOY Growth of 17%-23%, Adjusted EBITDA of $595-$625 million, Representing YOY Growth of 40%-47%, and Non-GAAP Diluted EPS of $4.00-$4.20, Representing YOY Growth of 44%-52% SAN DIEGO, Oct. 31, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the third quarter ended September 30, 2024, and provided an update on its recent corporate activities and outlook. "Our robust third quarter financial results highlight the strong execution and accelerating momentum we have across our business and exceeded expectations with total revenue growth of 34% and adjusted EBITDA growth of 60%. Based on the strong performance year-to-date, we have raised our 2024 guidance ranges and expect the advancement of our ENHANZE pipeline and new nominations from two global licensing agreements to support our future growth trajectory," said Dr. Helen Torley, president and chief executive officer of Halozyme. "In the quarter, the announcement of two highly anticipated partner approvals in the U.S. for Roche's TECENTRIQ HYBREZA and OCREVUS ZUNOVO reinforces ENHANZE's track record of 100% phase 3 study and subsequent regulatory success. The new nominations for ENHANZE from argenx, for a total of six targets, and ViiV Healthcare, for an additional undisclosed target, further demonstrate the value of our leading technology for rapid, large volume subcutaneous delivery." Recent Partner Highlights: In October 2024, argenx initiated two studies evaluating VYVGART® Hytrulo with ENHANZE®, a Phase 3 study for adult patients with ocular myasthenia gravis ("oMG") and a Phase 2 study for kidney transplant recipients with antibody mediated rejection ("AMR"). In October 2024, Janssen announced the European Commission approved DARZALEX® SC for the treatment of patients newly diagnosed with multiple myeloma ("NDMM") who are eligible for autologous stem cell transplant ("ASCT") in combination with bortezomib, lenalidomide, and dexamethasone ("D-VRd"). In September 2024, argenx expanded its global collaboration and license agreement nominating four additional targets that provides them exclusive access to our ENHANZE® drug delivery technology for a total of six targets. Under the terms of the expanded exclusive agreement, we received upfront payments of $7.5 million per target nomination for a total of $30.0 million. argenx is obligated to make future milestone payments of up to $85.0 million per new nominated target, subject to achievements of specified development, regulatory and sales-based milestones. We are also entitled to receive royalties on net sales of commercialized products with our ENHANZE® technology. In September 2024, ViiV expanded its global collaboration and license agreement providing ViiV the ability to exclusively access our ENHANZE® drug delivery technology for one additional undisclosed target. In September 2024, Roche announced the U.S. Food and Drug Administration ("FDA") approved OCREVUS ZUNOVO™ with ENHANZE® as a twice a year ten-minute subcutaneous ("SC") injection for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis. In September 2024, Roche announced the FDA approved TECENTRIQ HYBREZA™ with ENHANZE® for all approved adult indications of intravenous ("IV") TECENTRIQ® and was made available to patients, resulting in a $12.0 million milestone payment. In September 2024, Janssen announced the submission of a supplemental Biologic License Application to the FDA for approval of a new indication of DARZALEX FASPRO® in combination with D-VRd for the treatment of adult patients with NDMM for whom ASCT is deferred or who are ineligible for ASCT. In August 2024, the FDA designated Janssen's Biologics License Application ("BLA") priority review status for amivantamab SC in combination with LAZCLUZE™ for currently approved or submitted indication of IV in certain patients with non-small cell lung cancer. In August 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771 with ENHANZE® for treatment of chronic inflammatory demyelinating polyneuropathy/Multifocal Motor Neuropathy. In July 2024, Janssen announced the FDA approved DARZALEX FASPRO® for an additional indication in NDMM patients who are eligible for ASCT in combination with D-VRd. In July 2024, argenx announced the National Medical Products Administration approved the BLA of efgartigimod SC for generalized myasthenia gravis in China. In July 2024, Acumen initiated a Phase 1 study of sabirnetug ("ACU193") co-formulated with ENHANZE® for the treatment of early Alzheimer's disease. Third Quarter 2024 Financial Highlights: Revenue was $290.1 million, compared to $216.0 million in the third quarter of 2023. The 34% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenue. Revenue for the quarter included $155.1 million in royalties, an increase of 36% compared to $114.4 million in the third quarter of 2023, primarily attributable to increases in revenue of DARZALEX® SC and Phesgo®, and the prior year launch of VYVGART® Hytrulo. Cost of sales was $49.4 million, compared to $54.8 million in the third quarter of 2023. The decrease was primarily due to lower device and bulk rHuPH20 sales. Amortization of intangibles expense was $17.8 million, compared to $20.3 million in the third quarter of 2023. The decrease was primarily due to an impairment charge of $2.5 million recognized in the prior year to fully impair the TLANDO® product rights intangible asset. Research and development expense was $18.5 million, compared to $17.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense. Selling, general and administrative expense was $41.2 million, compared to $35.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense and consulting and professional service fees. Operating income was $163.2 million, compared to $88.3 million in the third quarter of 2023. Net Income was $137.0 million, compared to $81.8 million in the third quarter of 2023. EBITDA was $183.6 million, compared to $124.6 million in the third quarter of 2023. Adjusted EBITDA was $183.6 million, compared to $114.9 million in the third quarter of 2023.1 GAAP diluted earnings per share was $1.05, compared to $0.61 in the third quarter of 2023. Non-GAAP diluted earnings per share was $1.27, compared to $0.75 in the third quarter of 2023.1 Cash, cash equivalents and marketable securities were $666.3 million on September 30, 2024, compared to $336.0 million on December 31, 2023. The increase was primarily a result of cash generated from operations. Financial Outlook for 2024 The Company is raising its financial guidance for 2024. For the full year 2024, the Company expects: Total revenue of $970 million to $1,020 million, representing growth of 17% to 23% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $550 million to $565 million, representing growth of 23% to 26% over 2023. Adjusted EBITDA of $595 million to $625 million, representing growth of 40% to 47% over 2023. Non-GAAP diluted earnings per share of $4.00 to $4.20, representing growth of 44% to 52% over 2023. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Table 1. 2024 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the third quarter ended September 30, 2024 today, Thursday, October 31, 2024 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA and Non-GAAP diluted earnings per share, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items such as changes in contingent liabilities and inventory adjustments. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's financial outlook for 2024) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2018 年 11 月，61岁的张大爷因为咳嗽加重去医院进行详细的检查，被确诊为非小细胞肺癌--IV 期（T4N2M1a）并且已经扩散到了大脑，幸运的是，他的基因检测存在EGFR 19 外显子缺失（EGFR经典突变）。因此，他吃了2代靶向药埃克替尼后效果很好，获得部分缓解 (PR)。 直到2021年3月，他的复查结果显示肺部和肝脏都出现了新的肿瘤，第二次的基因检测结果也显示出现了耐药突变，于是张大爷换上了3代靶向药阿美替尼，不幸的是，只缓解了短短4个月，病情就出现了快速进展，肝转移灶增大，肝肿瘤数量增加。 张大爷做了第三次的基因检测，显示狡猾的肿瘤又出现了新的耐药突变EGFR cis -C797S 突变，但是针对3代药物耐药的4代靶向药都还没上市。幸运的是，当时国内有一项临床试验，正在评估一款国研PD-1（信迪利单抗）联合方案治疗EGFR靶向耐药病情进展的肺癌患者的疗效和安全性，张大爷顺利的入组了。 接受治疗后，张大爷的病灶控制稳定，截至文献发表时，张大爷已经靠着信迪利单抗联合的治疗方案获得了超过15个月的无进展生存期 (PFS) ！ 越来越多的新方案为耐药患者点亮新的希望！ 在中国人群中，EGFR突变是最常见的突变类型，约40%的患者携带这一突变类型，随着一代/二代/三代靶向药物的临床应用，患者总体生存时间从最初令人扼腕的12个月生存期，逐步延长至令人鼓舞的22个月，乃至更长的38个月，而在部分前沿研究中，患者的整体生存时间更是突破性地跨越了4年的里程碑。其中，三代明星靶向药奥希替尼功不可没！ 然而，无论什么方案，不可避免的耐药通常在9-12个月出现，也成为肺癌病友面临的新的生存考验，众多病友迫切等待破解耐药的“续命”方案！ 好消息是，近两年，众多备受关注的4代靶向药，新型ADC药物，免疫联合疗法等取得了众多突破，给耐药陷入绝境的患者重新点燃希望！疾病控制率可高达100%！多款4代靶向药，抗体偶联药物，免疫联合方案纷纷出炉...2024，奥希替尼耐药的患者将有更多治疗选择！ （注：不想看数据的病友可以直接提交资料至医学部申请新药方案） 一、疾病控制率超90%！免疫双抗AK112率先冲破耐药瓶颈 依沃西单抗注射液（AK112）是一款国研的新型PD-1/VEGF双特异性抗体，可阻断PD-1与PD-L1和PD-L2的结合，并同时阻断VEGF与VEGF受体的结合。这种独特的“肿瘤免疫+抗血管生成”双靶点协同抗肿瘤的作用机制，为耐药的非小细胞肺癌患者带来新的希望。 好消息是，2024年5月，依沃西单抗注射液（商品名：依达方）上市，适应症为联合培美曲塞和卡铂，用于经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者的治疗。 2024年3月，康方生物在欧洲肺癌大会（ELCC）更新了依沃西联合化疗一线治疗晚期NSCLC的2期临床研究更新数据。其中，①在初治的EGFR/ALK野生型非小细胞肺癌患者中，鳞状非小细胞肺癌患者的客观缓解率(ORR)为 77.8% ，疾病控制率(DCR)高达 100% ；②在EGFR-TKI治疗失败的EGFR突变的晚期非鳞状非小细胞肺癌患者中，ORR为 68.4% ，DCR为 94.7% 。 新药申请 好消息 依沃西单抗注射液（AK112） 目前在国内多中心开展临床试验，招募EGFR耐药的肺癌患者，想申请的病友可以提交资料至全球肿瘤医生网医学部 （4006667998） 进行评估。 二、疾病控制率高达100%！EGFR+耐药有救了，新型NK免疫疗法点亮希望！ SNK01疗法是美国NKGen公司基于自然杀手（NK）细胞开发的免疫疗法。这种新型的自体NK细胞疗法，具有更强的抗癌效果，已发现对几类肺癌细胞系具有杀伤作用。 在2023的ASCO 大会上，自体自然杀伤（NK）细胞疗法SNK01与西妥昔单抗联合的全新方案， 又给EGFR靶向治疗失败的肺癌患者带来全新生机！ I/IIa 期临床试验：NK细胞联合方案疾病控制率高达100% 这项研究共纳入了12 名既往EGFR靶向治疗失败的EGFR+非小细胞肺癌患者，接受SNK01 与吉西他滨/卡铂 (n=6) 或吉西他滨/卡铂/西妥昔单抗 (n=6) 的联合治疗。 结果显示：客观反应率为 25% (3/12)，疾病控制率 (DCR) 高达 100% ，其中 3/12 名患者出现部分反应 (25%)，9/12 名患者病情稳定 (75%)。这意味着 所有EGFR靶向治疗失败的患者接受NK细胞联合方案后，靶病灶出现了不同程度的缩小或控制稳定 ！ 研究人员兴奋的说，“这项研究的结果很有希望，值得进一步评估。SNK01 的潜在治疗益处令人感到兴奋，特别是对于不断增长的难治性癌症患者群体。” 三、明星ADC冲破耐药，HER3-DXd疾病控制率超70%！ HER3-DXd（U3-1402）是日本第一三共制药公司研发的Her3抗体偶联体药物，主要的治疗机理是通过U3-1402与Her3蛋白结合，然后将携带的治疗性药物送入肿瘤细胞内，以杀死肿瘤细胞。 U3-1402这款药物可以解决多种耐药机制，包含EGFR基因的C797S突变、MET基因扩增、HER2蛋白突变、BRAF基因和PIK3CA基因突变所导致的耐药，最重要的是也不需要管什么基因突变导致的耐药，U3-1402都可能起作用。 临床数据： HER3-DXd（U3-1402）代号为HERTHENA-Lung01的临床试验更新数据显示，纳入的患者共有225例，均已经接受过EGFR抑制剂治疗以及铂类化疗，其中，209例患者（93%）已经接受过了第三代EGFR抑制剂治疗及铂类化疗。在这部分患者当中，HER3-DXd的整体缓解率仍然达到了29.2%，疾病控制率达到72.7%！患者的中位无进展生存期为5.5个月，中位总生存期为11.9个月。 这对于平均经过了4线以上治疗后耐药的患者而言是非常难能可贵的。除了疗效优异，安全性也可控。 新药申请 好消息 HER3-DXd（U3-1402） 目前在国内多中心开展临床试验，招募EGFR耐药的肺癌患者，想申请的病友可以提交资料至全球肿瘤医生网医学部进行评估。 四、耐药后超60%患者显著缓解！全球首款EGFR+HER3双靶点ADC疗效卓越 BL-B01D1是中国百利药业自主开发的全球首个靶向EGFR和HER3双靶点的ADC，其中HER3更是已经被验证有用于治疗EGFR抑制剂耐药患者的潜力。 2023年ASCO大会上报道了BL-B01D1治疗实体瘤的I期临床研究数据，其中38例经治EGFR突变非小细胞肺癌患者，全部接受过靶向治疗，其中89%为3代靶向药（奥希替尼、阿美替尼等），这些经治的EGFR突变患者客观缓解率（ORR）高达63.2%，疾病控制率高达89.5%。 五、肺癌第4代靶向药BBT-176公布更新研究数据！ BBT-176 是一种广谱、高效的第 4代EGFR 靶向药，对包括 T790M 和 C797S 在内的致敏和治疗出现的 EGFR 突变具有增强的活性。此前的临床数据数据显示，这款药物在多名患者中观察到有希望的早期疗效信号，包括那些携带EGFR C797S 三重突变的患者，无论是针对获得性耐药还是早期治疗，都有可能治疗或预防脑转移。 2023年世界肺癌大会（WCLC）上公布了备受肺癌病友们期待的4代靶向药BBT-176的更新数据。 截至 2023 年 3 月 29 日，已有 44 名既往接受过至少一种 EGFR靶向 治疗的EGFR突变患者患者（19 名来自 BID 队列的患者）接受了 BBT-176 治疗。 结果显示： 11 名患者的血浆中检测到EGFR三重突变基因（外显子 19 del/T790M/C797S 或 L858R/T790M/C797S），目前显示出早期功效信号。 研究人员说“我们相信 BBT-176有潜力成为广谱第四代 EGFR TKI，并有能力通过组合进一步增强治疗。 六、近50%患者肿瘤明显缩小！新药物组合成功打破EGFR耐药困境！ 奥希替尼耐药后，大部分重新进行基因检测的患者会发现自己出现了一种新的耐药突变--MET过表达和/或扩增。研究发现，这是对奥希替尼最常见的耐药机制之一，目前还没有获批的靶向药。 奥希替尼联合赛沃替尼 的全新药物组合方案突破了这一耐药瓶颈。 在一项研究中，所有肺癌患者在接受奥希替尼治疗后出现疾病进展，其中62%患者的肿瘤伴有MET过表达和/或扩增，超过三分之一（34%）的患者为MET高表达。 截至2021年8月，在MET高水平表达的耐药患者中，组合疗法的客观缓解率高达（ORR）49%，其中未接受过化疗的患者客观缓解率高达（ORR）52%。这意味着，近一半的患者在接受奥希替尼联合赛沃替尼治疗后，病灶缩小了30%以上，甚至消失！详细疗效数据请见下表： 此外，值得病友们振奋的是，分别作用于MET和EGFR靶点的两款国研高选择性激酶抑制剂伯瑞替尼和PLB1004也开启了联合用药研究，目前国内多家中心已启动招募EGFR抑制剂治疗后由于MET扩增而复发的晚期非小细胞肺癌患者！ 七、“续命”疗法阿米万他单抗联合化疗申请上市！ 近日，肺癌EGFR靶点的“明星”靶向药阿米万他单抗（amivantamab-vmjw ，Rybrevant) 向FDA提交了新适应症的上市申请，寻求阿米万他单抗与铂类化疗联合用于治疗携带 EGFR 外显子 19 缺失的局部晚期或转移性非小细胞肺癌患者的批准。这意味着，如果一切顺利，让病友们苦苦等待的破解奥希耐药的首款“续命”新方案有望获批！ 阿米万他单抗是一种新型的EGFR-MET双特异性抗体，靶向激活和耐药的EGFR和MET突变和扩增。此次提交上市申请是基于代号为MARIPOSA-2 的全球试验，入组的患者都是奥希替尼耐药的EGFR外显子 19 缺失或 L858R 突变的晚期或转移性非小细胞肺癌患者。 2023 年 ESMO 大会上公布的最新研究结果显示： 与单独化疗相比，阿米万他单抗联合化疗，以及阿米万他单抗联合拉泽替尼 (Leclaza) 和化疗，显著改善了无进展生存期 (PFS)。 与单独化疗相比，化疗中添加阿米万他单抗和拉泽替尼可使进展或死亡风险降低 56% ； 与单独化疗相比，在化疗中添加阿米万他可使进展或死亡风险降低 52% 。 3大新药启动临床招募，EGFR耐药患者迎来曙光 除了上面的7款新疗法，全球还有多款药物在克服奥希替尼耐药上展现出巨大潜力！ 国内也正在开展多项临床研究并已有大量患者通过全球肿瘤医生网成功入组接受治疗，目前仍可申请。 01 Ifebemtinib（IN10018） 药品名称： 甲磺酸哆希替尼片 作用靶点： EGFR 研发公司： 应世生物 药物介绍： 是一种高效、高选择性的FAK抑制剂。IN10018早期临床数据显示了其良好的安全性和多癌种有效性。最新研究成果表明IN10018有望通过克服肿瘤基质纤维化屏障和调节肿瘤免疫抑制性微环境，实现突破肿瘤防御机制，有效克服耐药和转移，成为多种治疗方案的基石分子。 适应症： EGFR突变肺癌 入组条件（部分）： 1.有EGFR-TKI敏感性相关的EGFR突变，包括Ex19del或L858R。除外EGFR-TKI敏感突变，可合并其他EGFR突变类型如T790M等。 2.既往经三代EGFR-TKI治疗进展，并接受过1-2线化疗（需至少包括 1线含铂化疗），且化疗进展或不耐受的NSCLC受试者. 02 SKB264 药品名称： SKB264 作用靶点： EGFR 研发公司： 科伦博泰生物 药物介绍： 注射用SKB264是靶向人滋养层细胞表面抗原2（TROP-2，在多种上皮来源肿瘤中高表达）的抗体偶联药物（ADC）药物，其偶联方式和毒素小分子具有自主知识产权，拟用于恶性实体瘤的治疗。早期临床研究结果显示了SKB264在转移性实体瘤患者中良好的耐受性、安全性和令人鼓舞的抗肿瘤活性。 适应症： EGFR突变肺癌 入组条件（部分）： 1.经肿瘤组织学或细胞学或血液学证实存在EGFR敏感突变；2.既往接受过EGFR-TKI治疗且治疗失败；3.既往接受过针对局部晚期或转移性NSCLC的至少一种含铂化疗失败。 03 PLB1004+伯瑞替尼 药品名称： 安达替尼（PLB1004）+伯瑞替尼 作用靶点： c-Met过表达 研发公司： 鞍石生物 适应症： EGFR-TKI治疗失败后伴c-Met过表达或c-Met扩增 招募信息（部分）： 经组织学或细胞学确诊的，经临床诊断为不能手术治疗且不能接受根治性同步放化疗的局部晚期（ⅢB/ⅢC期）、转移性或复发性（IV期）NSCLC的患者； 既往未接受过针对晚期/转移性疾病的任何系统性抗肿瘤治疗； 携带与EGFR-TKI敏感性相关的EGFR突变（包括外显子19缺失和外显子21 L858R突变）； 经中心实验室确认c-Met过表达：通过IHC检测，组织样本≥50%肿瘤细胞的染色强度3+； 经影像评估，有可测量病灶(肿瘤大于10mm或淋巴结大于15mm) 随着这些新药、新治疗方法的研发，癌症的治愈率与癌症患者的生存期均优于以往。国内的患者有机会选择更好的治疗方法，获得更好的治疗结局。 参考资料： 1.https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1298389/full 2. Souria JC, et al. New Engl J Med. 2018;378:113-125. 3. Ramalingam SS, et al. J Thorac Oncol. 2022:17(9):S67-S68.