Another predictive marker for immunotherapy is released; HR+ breast cancer prognosis AJCC staging system may be changed|Tumor News

*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 the editor WeChat yxj_oncology to obtain) Key points: ANNALS OF ONCOLOGY: tTMB is a significant and independent predictor of PD-L1 status.
JNCI: HR+ breast cancer prognosis stage IA under the AJCC staging system may be expanded New drug: Wanchun Pharmaceutical's first original innovative drug, Pranabrin, obtained FDA priority review qualification.
New drug: Innovative FGFR inhibitor was approved by FDA accelerated 01ANNALS OF ONCOLOGY: tTMB is a significant and independent predictor outside of PD-L1 status in Ⅲ In the phase KEYNOTE-061 trial (NCT02370498), compared with paclitaxel, pembrolizumab in the second-line treatment of PD-L1 combined positive score (CPS) ≥1 gastric/gastroesophageal junction (GEJ) adenocarcinoma failed to significantly improve overall Lifetime.

The researchers conducted an exploratory analysis to determine the correlation between tissue tumor mutational burden (tTMB) status, CPS, microsatellite highly unstable (MSI-H) status, and clinical outcome.

The results of the study proved for the first time that there is a strong correlation between tTMB and the efficacy of gastric/GEJ adenocarcinoma patients treated with pembrolizumab; tTMB is a significant and independent predictor of PD-L1 status.

The results of univariate analysis of screenshots from the official website show: Objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) of patients treated with whole exome sequencing-tTMB (WES-tTMB) and pembrolizumab Significantly related (all P<0.
001), but not related to paclitaxel-treated patients (all P>0.
6).

The area under the WES-tTMB and remission ROC (receiver operating characteristic curve) of the pembrolizumab group was 0.
68 (95% CI, 0.
56-0.
81), and the paclitaxel group was 0.
51 (95% CI, 0.
39-0.
63).The correlation between WES-tTMB and CPS in the two treatment groups was low (r≤0.
16).

After correction for CPS, WES-tTMB was still significantly correlated with all clinical endpoints of pembrolizumab treatment.
After excluding known MSI-H tumors, WES-tTMB was still significantly correlated with PFS and OS (n = 26).

02JNCI: HR+ breast cancer prognosis stage IA under the AJCC staging system may expand the scope of a retrospective analysis "Expanding Criteria for Prognostic Stage IA in Hormone" published online by Journal of the National Cancer Institute (JNCI) on May 28, 2021 Receptor-Positive Breast Cancer shows that regardless of the T classification of No-1 disease, breast cancer patients with 21 gene recurrence score (RS) <18 have a very high 5-year disease-specific survival rate (DSS), and you can consider using this The critical value is further modified AJCC staging system.

 Screenshots of the official website.
Using monitoring, epidemiology and final results data, the researchers analyzed T1-3, N0-3, M0 hormone receptor positive (HR) positive/HER2-negative breast cancer patients who received treatment from 2010 to 2015 until 2016 Follow-up data.

 The results of the study showed that among the 154,050 patients with a median follow-up of 49 months, 60886 (39.
5%) had a measurable RS score: 13570 (22.
3%) patients had RS score <11, 22719 (37.
3%) patients had RS score For 11-17, 16521 patients (27.
1%) had an RS score of 18-25, and 8076 patients (13.
3%) had an RS score of ≥26.

The pathological prognosis of stage IA patients (n = 114, 910, 74.
6%) had a 5-year DSS of 98.
8%. Among the No-1 patients with RS score less than 18, they were not staged as pathological prognosis stage IA according to current standards, but their 5-year DSS was excellent, and there was no statistically significant difference from pathological prognosis stage IA patients (97.
2%-99.
7% , P>0.
05); For patients with an RS score of 18-25, compared with patients with pathological prognosis stage IA, the DSS of T2N0 patients was slightly reduced (2.
3%), and the DSS of T1-2N1 patients was also reduced to a certain extent (4.
2%-6.
4 %) (P <0.
001).

03 New drug: Wanchun Pharmaceutical's first original innovative drug, prenabulin, was given FDA priority.
On June 1, Wanchun Pharmaceutical announced that the new drug application (NDA) of "Prenabulin for Injection" has officially been approved by American Foods.
The Drug Administration (FDA) accepted (NDA215340), the indication for this application is for severe neutropenia (CIN) caused by chemotherapy; at the same time, Pranabrin was included in the priority review by the FDA.

04New drugs: Innovative FGFR inhibitors received accelerated approval from the FDA May 28, 2021 local time, FGFR inhibitor infigratinib received accelerated approval from the FDA for the treatment of locally advanced or metastatic cholangiocarcinoma (CCA) carrying FGFR2 fusion or rearrangement Treated patients.

Infigratinib is an oral, ATP-competitive, FGFR tyrosine kinase inhibitor.

In a pivotal clinical trial in patients with advanced, unresectable CCA, infigratinib can significantly shrink tumors.

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