Durvalumab

– Continued execution across Ampligen® (rintatolimod) clinical development programs in areas with critical unmet needs, especially in the high-value pancreatic cancer and Long-COVID spaces – Expected milestones over the course of the next 18 months provide significant value-driving opportunities, including some trials being partially funded by the National Cancer Institute, AstraZeneca and Merck Jan. 15, 2025 -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today highlighted key clinical, regulatory and corporate milestones achieved over 2024 and outlined its expected upcoming milestones. “It is clear that 2024 was a foundational year for AIM on the clinical, regulatory and corporate fronts. Without a doubt, our team continued to drive our strategy forward and deliver results. We believe this progress has positioned AIM for an exciting 2025 and the opportunity to drive value for our stockholders,” stated Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. “Looking ahead, we believe we are poised for an exciting 2025 with a number of key milestones expected over the next 18 months across important clinical trials addressing major unmet medical needs. Certain of these trials are being funded in part by major oncology interests such as the National Cancer Institute, AstraZeneca and Merck, which we believe emphasizes their great potential to change lives for the better. Our team is committed to the seamless execution of our clinical development programs and, if successful, we believe each holds the potential to drive significant value in the near and long term.” Metastatic Pancreatic Ductal Adenocarcinoma Program Commenced enrollment and dosing in DURIPANC Phase 1b/2 study combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer; Announced that the first dose level was generally well-tolerated in the DURIPANC Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer; and Reported positive preliminary data from Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer. Phase 2 Locally Advanced Pancreatic Adenocarcinoma Program Received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer; and Announced the publication of new positive data analysis from a long-term Early Access Program studying Ampligen for the treatment of advanced pancreatic ductal adenocarcinoma. The Company sought FDA guidance on expansion of inclusion criteria and treatment arms, and then subsequently amended the study protocol. The study is recruiting patients. These adjustments are also expected to result in substantial reductions in clinical costs. Phase 2 Recurrent Ovarian Cancer Program Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer. Phase 2 Post-COVID Conditions Program Reported positive topline results from the Company’s Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue (“AMP-518”); and Reported an analysis of the AMP-518 clinical trial, based upon statistically significant data, which supports the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe post-COVID-19 condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial. Further, the Company was also granted two important patents covering Ampligen for the treatment of: Endometriosis, a painful chronic condition that affects nearly 10% of women of reproductive age, or approximately 6.5 million women in the United States. This patent was granted in the United States. The Post-COVID Condition of Fatigue. This method and compositions patent was granted in the Netherlands. Additionally, AIM successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen. The Company announced the publication of new pre-clinical data of Ampligen as part of a combinational therapy in the treatment of melanoma. Metastatic Pancreatic Ductal Adenocarcinoma Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center Q1 2025: Complete Phase 1b Early Q2 2025: Launch of Phase 2 Q2/Q3 2026: Last patient enrolled in Phase 2 Locally Advanced Pancreas Cancer (LAPC) Phase 2 Ampligen Combined with Standard of Care (SOC) versus SOC Alone Following First-Line Therapy in Subjects with LAPC (NCT05494697); AIM funded Q1 2025: Buffet Cancer Center expected to enroll first subject H1 2025: first subject dosed Refractory Melanoma Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute H1 2025: First patient dosed Stage 4 Triple Negative Breast Cancer Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute Q2 2026: Expected completion of enrollment Advanced Recurrent Ovarian Cancer Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck H1 2025: Expected last patient dosed and completion of study Advanced Recurrent Ovarian Cancer Phase 2 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (NCT02432378); Grant funded by the National Cancer Institute H1 2025: First patient dosed Post COVID Chronic Fatigue Conditions / Long Covid Phase 2 Study to Evaluate the Efficacy and Safety of Ampligen in Patients with Post-COVID Conditions (NCT05592418); AIM funded Q1 2025: Final approved study results to be published on clinicaltrials.gov AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. The content above comes from the network. if any infringement, please contact us to modify.

点上方蓝字“ioncology”关注我们， 然后点右上角“…”菜单，选择“设为星标” 前言：2024年世界肺癌大会（WCLC）上公布了多项非小细胞肺癌（NSCLC）围手术期治疗重磅研究成果，《肿瘤瞭望》特将重要研究进行回顾整理，以飨读者。 01 病理学缓解与无事件生存期（EFS）的相关性：来自III期KeyNote-671研究 KeyNote-671研究是一项III期、随机、双盲、安慰剂对照的临床试验，旨在探索对于可切除的Ⅱ-Ⅲ期、初治非小细胞肺癌（NSCLC）患者，在含铂双药治疗基础上进一步联合针对PD-1的免疫检查点抑制剂帕博利珠单抗能否改善患者预后。符合入组标准的患者按1:1的比例随机分为单纯化疗或化疗联合帕博利珠单抗，上限接受4周期治疗。末次治疗后4~8周内接受手术，术后接受13周期安慰剂或帕博利珠单抗治疗。首次数据分析时，联合治疗组和单纯化疗组病理完全缓解（p-CR）分别为18.1%和4%，主要病理缓解（MPR）分别为30.2%和11.0%，24个月EFS率分别为62.4%和40.6%，HR=0.58；第二次期中分析时，两组36个月总生存（OS）率分别为71.3%和64.0%，HR=0.72。本研究公布了患者病理学缓解与EFS之间的相关性。研究纳入接受手术且病理标本可评估的患者。联合治疗组和单纯化疗组分别入组320例和300例患者，基线特点均衡可比且与意向治疗（ITT）人群类似。两组平均肿瘤残留率分别为29.5%和52.0%，其中残留0~5%的患者比例分别为31.9%和12.3%，残留5%~30%的患者比例分别为19.1%和14.7%，残留30%~60%的患者比例分别为31.6%和38.0%，残留＞60%的患者比例分别为17.5%和35.0%，残留比例越高，患者预后越差。4组 HR值分别为0.58、0.73、0.65和0.90。 不同残留比例与患者预后的关系 研究者认为，无论患者接受的治疗手段，更高的肿瘤残留比例与更差的EFS有关。 02 纳武利尤单抗联合或不联合Relatlimab新辅助治疗可切除NSCLC患者的疗效及安全性：一项随机、多队列研究的长期随访 Relatlimab是一款针对Lag-3的单克隆抗体，本研究旨在探索对于可切除NSCLC患者，在纳武利尤单抗的基础上进一步联合Relatlimab是否能改善患者疗效。研究纳入Ⅰ-Ⅲ期初治、组织病理学确认的NSCLC患者，按1:1:1的比例随机分为三个队列：队列1给予2周期纳武利尤单抗240 mg；队列2给予2周期纳武利尤单抗240 mg，联合Relatlimab 80 mg；队列3给予纳武利尤单抗240 mg，联合Relatlimab 240 mg，三组的样本量均为30例。两周期治疗后，患者接受手术，术后接受标准治疗。队列1和队列2，PD-L1≥50%的患者占比分别为33.3%和23.3%。MPR分别为26.7%和33.3%，p-CR分别为13.3%和18.5%，淋巴结降期率分别为28.6%和66.7%。队列1，Ib、IIa、IIb和IIIa期患者MPR分别为12.5%、25.0%、50.0%和12.5%，2年无病生存（DFS）率和OS率分别为75.3%和92.3%；队列2，4种分期的MPR分别为66.7%、0%、11.1%和22.2%。2年DFS率和OS率分别为69.1%和88.6%。 两组患者的MPR 这项更新后的研究数据确认了纳武利尤单抗联合Relatlimab新辅助治疗的可行性，2年OS和DFS的数据令人鼓舞。 03 伊沃西单抗单药或联合化疗新辅助治疗可切除NSCLC患者的疗效及安全性：一项II期临床研究 伊沃西单抗是一款针对PD-1和VEGF的双特异性抗体，本研究旨在探索该药新辅助治疗NSCLC患者的疗效及安全性。研究纳入组织病理学确认的Ⅱ-Ⅲ期可切除、驱动基因突变阴性的NSCLC患者，符合入组标准的患者接受伊沃西单抗20 mg/kg，每三周一次(队列1)或伊沃西单抗20 mg/kg或30 mg/kg联合化疗，每三周一次(队列2)。患者接受3~4周期治疗后，末次治疗4~6周内接受手术治疗，术后接受16周期伊沃西单抗维持治疗。 依沃西单抗单药组和联合治疗组分别有10例和39例患者接受R0切除，p-CR分别为30.0%和43.6%，MPR分别为60.0%和71.8%。在队列2中，PD-L1＜1%和＞1%的患者，p-CR分别为22.2%和50.0%，MPR分别为66.7%和71.4%，接受20 mg/kg和30 mg/kg药物治疗的患者，p-CR分别为40.0%和47.4%，MPR分别为70.0%和73.7%。队列1和队列2的中位随访时间分别为17.6个月和8.9个月，中位EFS均未达到，12个月EFS率分别为81.8%和80.3%，两组客观缓解率（ORR）分别为81.8%和81.6%，疾病控制率（DCR）分别为90.9%和95.9%。3级不良反应发生率分别为36.4%和32.7%，严重不良反应发生率分别为18.2%和2.0%，因不良反应而导致手术取消的患者均为0%，3级以上免疫相关不良反应发生率分别为36.4%和2.0%。 两组的病理学缓解 围手术期伊沃西单抗单药或联合化疗治疗可切除NSCLC患者展示了较高的p-CR和MPR，安全性可管理。 04 化疗联合免疫及放疗新辅助治疗III期N2的 NSCLC患者的疗效及安全性：一项单臂、II期临床研究(WJOG 12119L研究) 化疗联合免疫新辅助治疗是可切除NSCLC患者的标准治疗手段，这一单臂临床研究旨在探索在此基础上进一步联合放疗能否改善患者预后，其主要研究终点MPR在前期数据报道中为63%，满足预先的假设，p-CR为23%。本研究报道了其关键次要终点，包括无进展生存期（PFS）、OS和安全性的数据。 研究纳入可手术切除的III期N2 NSCLC患者，符合入组标准的患者接受培美曲赛40 mg/m2，第1/8/15/22/29天给药，卡铂AUC＝2，放疗总剂量为50Gy，度伐利尤单抗1500 mg，第1/29天给药，随后患者接受手术，术后给予度伐利尤单抗1年的维持治疗，主要研究终点MPR为63%，p-CR为23%。 研究共纳入30例患者，分期为IIIa和IIIb的患者占比分别为70%和30%，鳞癌和非鳞癌患者占比分别为37%和63%，携带EGFR驱动基因突变的患者占比为20%，PD-L1＜1%、1~49%和≥50%的患者占比分别为33%、37%和30%。ITT人群中两年PFS率为43%，中位PFS为15.0个月，2年OS率为76%，中位OS未达到。因不良反应而导致治疗终止的患者占比为10%，严重不良反应发生率36%，3级以上不良反应发生率为48%。 病理缓解与患者EFS及OS的关系 05 围手术期度伐利尤单抗的疗效及安全性：III期AEGEAN研究的更新 AEGEAN研究是一项随机、安慰剂对照的III期临床研究，旨在探索对于可切除NSCLC患者，在化疗的基础上，进一步联合针对PD-L1的免疫检查点抑制剂度伐利尤单抗新辅助治疗及术后辅助治疗的疗效及安全性。研究纳入可切除的IIa-IIIb期NSCLC患者，体力状态（PS）评分0~1分，符合入组标准的患者按1:1的比例随机分为含铂双药化疗或在此基础上联合度伐利尤单抗治疗，4周期后接受手术治疗，术后接受度伐利尤单抗或安慰剂维持治疗。研究共进行两次期中分析，第一次期中分析时，p-CR有13个百分点的提高，EFS的HR=0.68。本研究旨在公布其长期随访数据。 更新后的联合治疗组和单纯化疗组的EFS分别为未达到和30.0个月，HR=0.69，鳞癌和非鳞癌患者HR分别为0.70和0.73，疾病分期为II期、IIIa期和IIIb期的患者，HR分别为0.82、0.60和0.81，PD-L1＜1%、1~49%和≥50%的患者，HR分别为0.69、0.73和0.71。接受顺铂和卡铂治疗的患者，HR分别为0.58和0.75，接受术后辅助治疗和未接受术后辅助治疗的患者，HR分别为0.62和0.83，达到p-CR和未达到p-CR的患者，两组HR分别为0.73和0.81。两组中位DFS均为未达到，HR=0.66，P＝0.0137，两组中位OS分别为未达到和53.2个月，HR=0.89，肺癌特异性生存时间均为未达到，HR=0.70，两组3级及以上不良反应发生率分别为43.6%和43.2%，分别导致了12.7%和6.3%的患者治疗终止，以及1.7%和1.0%的患者手术取消。 更新后的EFS数据 更新后的数据证实了度伐利尤单抗在围手术期治疗中给患者带来EFS的获益，并提高了DFS，安全性可管理，没有新的安全性信号出现。 06 阿来替尼或化疗术后辅助治疗ALK融合阳性NSCLC患者：ALINA研究的安全性数据 ALINA研究是一项随机对照临床研究，旨在探索术后分期为Ib-IIIa期ALK融合阳性NSCLC患者，给予阿来替尼或含铂双药治疗的疗效及安全性。主要研究终点为DFS。数据公布时，ITT人群的HR=0.24，中枢神经系统（CNS）DFS的HR为0.22，两组3级以上不良反应发生率分别为30%和31%，中位治疗持续时间分别为23.9个月和2.1个月，因不良反应而导致剂量降低的患者占比分别为26%和10%。较常见的3级以上不良反应包括肝功能损伤4.7%，磷酸肌酸激酶升高6.3%及肾功能损伤0.8%。 阿来替尼的不良反应 （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。