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AACR Day0 :风急天高猿啸哀

 八卦小和尚 2021-04-11

睡前太累了  先撸几个

十三爷是今年的Underwriting Supporter

Updates on the Treatment of Patients with Unresectable or Metastatic HER2+ Breast Cancer who Previously Received Anti-HER2 Therapies

安全性和疗效的整体大家耳熟能详

大家还是关心ILD/Pneu

CT167. Pooled analysis of drug-related interstitial lung disease (ILD) in 8 single-arm trastuzumab deruxtecan (T-DXd) studies

ILD及时监控处理还是可控的

半夜的时候小贵子会有2个更新

CheckMate-816,首个肺癌新辅助,主要终点pCR 24% vs 2.2%,关键次要终点MPR 36.9% vs 8.9%

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced results from the CheckMate -816 study, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). In the study, 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR, compared to 2.2% of patients treated with chemotherapy alone (Odds Ratio [OR] 13.94, 99% Confidence Interval [CI]: 3.49–55.75; p<0.0001), with pCR defined as no evidence of cancer cells in their resected tissue as assessed by a blinded independent pathology review. Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of disease.

Opdivo plus chemotherapy also demonstrated improvements in key secondary endpoints, including major pathological response (MPR). Four times as many patients treated with Opdivo plus chemotherapy vs. chemotherapy alone achieved MPR (36.9% vs 8.9%; OR 5.70, 95% CI: 3.16-10.26), meaning 10% or less of their tumor cells remained after neoadjuvant therapy.

CT184. First-Line (1L) nivolumab (NIVO) plus chemotherapy (chemo) versus chemo in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 Chinese subgroup analysis

CM659 global(CPS≥5) OS 14.3 vs 11.1 HR 0.71;PFS 7.6 vs 6.0 HR 0.68

CM659 CHN基线均衡(CPS≥5) OS 15.5 vs 9.6 HR 0.54;PFS 8.5 vs 4.3 HR 0.52

CT178. Olaparib plus pembrolizumab in patients with previously treated advanced solid tumors with homologous recombination repair mutation (HRRm) and/or homologous recombination deficiency (HRD): Initial results of the phase 2 KEYLYNK-007 study

CT163. CD73 inhibitor oleclumab plus osimertinib for advanced EGFRm NSCLC: First report of a Phase 1b/2 study

Osi在T790M-的历史数据:ORR 19% DCR 61% PFS 2.8mo,万一大样本结果也是类似,CD73 inhibition对duration有协同?怎么解释

CT227. A phase 1 multiple ascending dose study to investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of KD033 in subjects with metastatic or locally advanced solid tumors

Background: IL-2 and IL-15 signal through the shared IL-2/15 βγ receptor, but unlike IL-2, IL-15 does not expand regulatory T cells (Tregs). In addition, unlike IL-2, IL-15 does not mediate activation-induced cell death and is expected to have an improved therapeutic index compared to IL-2. KD033 is a fusion antibody molecule generated by combining a fully human, high affinity anti-human Programmed Death Ligand 1 (PD-L1) IgG1 antibody with the human IL-15 receptor alpha (IL15Rα) sushi domain and human IL-15 (IL-15). KD033 (or its mouse cross reactive surrogate molecule, srKD033) has been extensively characterized in multiple in vitro and in vivo nonclinical studies to understand the pharmacology, pharmacokinetic (PK) and toxicology properties. The fusion of anti-PD-L1 antibody to IL-15 significantly increases the maximal-tolerated dose (MTD) of srKD033 in mice compared to free-IL-15. The increased safety and efficacy of PD-L1-targeted IL-15 observed in pre-clinical studies warranted evaluation of KD033 in humans.

CT205. Design and rationale of a phase 1 study evaluating AMG 256, a novel, targeted, PD-1 antibody x IL-21 mutein bifunctional fusion protein, in patients with advanced solid tumors

Checkpoint inhibitors are a promising therapy for patients with solid tumors; however, many patients require additional therapies to maximize clinical benefit or overcome resistance. The type-1 cytokine interleukin-21 (IL-21) is a promising candidate for combination and has shown clinical activity in melanoma and renal cell cancer. IL-21 has also shown improved efficacy when combined with anti-programmed death (PD)-1 antibodies in preclinical models. AMG 256 is a bifunctional fusion protein comprising a PD-1-targeting antibody and IL-21 mutein designed to deliver IL-21 pathway stimulation to PD-1+ cells—a strategy that is designed to prime and extend the activity of cytotoxic and memory T cells and induce anti-tumor immunity. This first-in-human (FIH) study will assess safety, tolerability, and estimated dosing of AMG 256 monotherapy in patients with advanced solid tumors.

CT170. D-0316 in T790M NSCLC 


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