翻身农奴把歌唱
CheakMate-648撞线，不管是NIVO+CHEMO还是NIVO+IPI，都在PD-L1+及总人群中带来显著的OS获益
WORLD GI20： “免疫检查点抑制剂治疗胃癌及食管癌”
ESMO20：“CheckMate-577及KEYNOTE-590的结果”
ESMO Asia 2020：“IO in Upper GI Cancers”
凭借着之前的CM-649（1L PD-L1 CPS≥5 G/GEJC）、ATTRACTION-04（1L HER2(-) G/GEJC，日韩）和这次的CM-648（1L ESCC），NIVO在上消化道肿瘤的一线治疗中实现全面打通——不区分组织学分型和肿瘤部位；再加上CM-577（E/EGJC 术后辅助）、CM-473（2L ESCC）和ATTRACTION-02（2L GC），实现了完美翻身
后续关注
G/GEJC：KN-811（1L HER2+ G/GEJC）、KN-859（1L HER2- G/GEJC）、KN-585（NAC G/GEJC）、ATTRACTION-5（NAC G/GEJC）
EC：基本比较圆满，后面看下罗老师的 Atezolizumab+Tiragolumab
NIVO status 更新
下载链接：
https://www.ono-pharma.com/sites/default/files/en/ir/library/pipeline/20210201_2_en.pdf
由于鬼子的原图在一些地理概念上容易引起歧义，所以单独标注，原文可见上述链接
(PRINCETON, N.J., April 8, 2021) – Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab)plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
In the study, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumors express PD-L1 and in the all-randomized patient population at the pre-specified interim analysis. Additionally, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1.
Opdivo plus Yervoy also met its primary and secondary endpoints by demonstrating statistically significant and clinically meaningful improvement in overall survival in patients whose tumors express PD-L1 and in the all-randomized population. Opdivo plus Yervoy did not meet its other primary endpoint of progression-free survival by BICR in patients whose tumors express PD-L1.
The safety profiles of Opdivo and the combination of Opdivo and Yervoy were consistent with those previously reported.
“The results for these Opdivo-based combinations represent a significant advancement for patients with esophageal cancer who are often diagnosed after their disease has spread and would benefit from new therapeutic options,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “This study further demonstrates our commitment to pursue combination strategies that improve outcomes for patients with high unmet need, such as those with gastrointestinal cancers.”
The data from CheckMate -648 build upon those from CheckMate -649, together making Opdivo the first and only PD-1/L1 inhibitor to demonstrate superior first-line survival in upper GI cancers across histologies and tumor locations (stomach, gastroesophageal junction, and esophagus). They also add to the existing body of data demonstrating the clinical benefit of Opdivo in esophageal cancer, from the late-line metastatic setting to earlier stages of disease.
The company will complete an evaluation of the CheckMate -648 data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities. Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -648 clinical trial.
About CheckMate -648
CheckMate -648 is a randomized Phase 3 study evaluating Opdivo plus Yervoy or Opdivo plus fluorouracil and cisplatin against fluorouracil plus cisplatin alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.
The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1, for both Opdivo-based combinations versus chemotherapy. Secondary endpoints of the trial include overall survival and progression-free survival by BICR in the all-randomized population.
In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 24 months or until disease progression or unacceptable toxicity.
In the Opdivo plus chemotherapy arm, patients received treatment with Opdivo 240 mg on Day 1 and Day 15, fluorouracil 800 mg/m²/day on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² on Day 1 of four-week cycle. Patients received Opdivo for up to 24 months or until disease progression or unacceptable toxicity, and chemotherapy until disease progression or unacceptable toxicity.
About Esophageal Cancer
Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 604,000 new cases and over 544,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma (ESCC) and adenocarcinoma, which account for approximately 90% and 10% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region. The overall burden of ESCC is concentrated in Asia, where roughly 80% of the global cases occurred in 2020. The majority of esophageal cancer cases are diagnosed in the advanced setting and impact a patient’s daily life, including their ability to eat and drink. ESCC occurs most often in the upper and middle portions of the esophagus, whereas adenocarcinoma begins in the cells of mucus-secreting glands in the esophagus and most often occurs in the lower portion of the esophagus.