The PRODIGY study confirms the value of neoadjuvant chemotherapy for gastric cancer; the study of lorlatinib for ROS1-positive advanced NSCLC is about to open tumor information

*Only for medical professionals to read for reference, 1 minute a day, to give you professional "talking information" in the tumor circle! (If you need the original text of the literature, you can add to the editor's WeChat yxj_oncology to obtain) Key points: JCO: Neoadjuvant DOS chemotherapy can improve PFS in patients with resectable advanced gastric cancer.
/6 inhibitor approved clinical new drug: lorlatinib for ROS1-positive advanced lung cancer related research in China is about to open 01JCO: neoadjuvant DOS chemotherapy can improve patients with resectable advanced gastric cancer PFSPRODIGY is a neoadjuvant chemotherapy (docetaxel + oxa A phase III randomized study of Liplatin+S-1) (DOS)+Surgery+Auxiliary S-1 vs.
Surgery+Auxiliary S-1 in the treatment of resectable advanced gastric cancer.
The results of the study were recently published in JCO
.

The results show that neoadjuvant DOS chemotherapy can improve progression-free survival and is well tolerated
.

Screenshots from the official website 530 newly diagnosed locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma patients (cT2, 3/N+M0 or cT4/NanyM0, AJCC 7th edition) were randomly divided into the CSC group according to a ratio of 1:1 ( n=266) and SC group (n=264)
.

Intervention measures in the CSC group: neoadjuvant DOS chemotherapy + D2 surgery + postoperative S-1 adjuvant chemotherapy Intervention measures in the SC group: D2 surgery + postoperative S-1 adjuvant chemotherapy The results of the study showed that: compared with the SC group, the CSC group had progression-free survival The period was significantly improved (HR, 0.
70; 95% CI, 0.
52-0.
95; P=0.
023)
.

Two cases of grade 5 adverse events (febrile neutropenia and dyspnea) occurred during neoadjuvant therapy
.

02 New drug: domestically produced hytrapopag ethanolamine tablets were approved for marketing.
On June 17, the National Medical Products Administration (NMPA) announced that it had passed the priority review and approval procedure to approve Hengrui Medicine's class 1 innovative drug hytrapopag ethanolamine tablets Launched for use in adult patients with chronic primary immune thrombocytopenia (ITP) who have not responded well to treatments such as glucocorticoids and immunoglobulins and have an increased risk of bleeding due to thrombocytopenia and clinical conditions, and for the efficacy of immunosuppressive therapy Poor adult patients with severe aplastic anemia (SAA)
.

Among them, the SAA indication is conditional approval
.

 Herombopag Olamine is an orally absorbed small molecule non-peptide thrombopoietin receptor (TPOR) agonist, which activates TPOR by selectively binding to the transmembrane region of thrombopoietin receptor Dependent STAT and MAPK signal transduction pathways stimulate the proliferation and differentiation of megakaryocytes to produce platelets to promote platelet-up
.

03 New drug: Another domestic CDK4/6 inhibitor was approved for clinical use.
According to the information published by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, the BPI-16350 capsule of Betta Pharmaceuticals has obtained two clinical trials implied licenses and plans to develop Treat breast cancer
.

 BPI-16350 is a CDK4/6 inhibitor independently developed by the company.
It is intended to be developed as a single drug or combined with hormone therapy for the treatment of hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced stages Or for patients with metastatic breast cancer, it can also be used for the first-line, second-line or combination therapy of other Rb+ cancers
.

The clinical research indications for the drug approved this time are: BPI-16350 combined with fulvestrant or aromatase inhibitors in the treatment of breast cancer
.

04 New drug: Lorlatinib's research on ROS1-positive advanced lung cancer in China is about to start.
On June 15, 2021, CStone Pharmaceuticals (02616.
HK) announced that it will cooperate with Pfizer in the Greater China region for ROS1-positive advanced non-small cell lung cancer (NSCLC).
Joint research and joint development of lorlatinib
.

This upcoming clinical study in China is the world's first pivotal study of lorlatinib for ROS1-positive lung cancer
.

Lorlatinib is a third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI) that can pass through the blood-brain barrier
.
It was approved for marketing in the United States in November 2018 .

The phase III CROWN study confirmed that lorlatinib is better than the first-line treatment for ALK-positive NSCLC; lorlatinib also has excellent effects on intracranial lesions in patients with brain metastases, with an overall remission rate of 82% and a complete remission rate of 71%
.

Currently, lorlatinib has not yet been approved for listing in China
.

 References: [1] Kang YK, Yook JH, Park YK, et al.
PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer.
J Clin Oncol.
2021 (16): JCO2002914.
[2] https://mp.
weixin.
qq.
com/s/nPFDkiKeBTruWI62p5eWBA[3] https://mp.
weixin.
qq.
com/s/ RnBTSIqInvA2TiIexgwuTg[4] https://mp.
weixin.
qq.
com/s/670P3I8nGh009vFJaPhq6w