The world's first first-line treatment of SCLC with positive results of PD-1 inhibitor data announced!

*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 get it) Key tips: ASTRUM-005 mid-term analysis and announcement, Slulimumab shows good data! JAMA: Apatinib can further benefit PFS and OS in RAIR-DTC patients! New drug: oral small molecule PD-L1 inhibitors are approved for clinical use! New drug: Two domestically produced generic lenvatinib have been approved for marketing! 01 Frontier: ASTRUM-005 mid-term analysis was announced, and Slulimab showed good data! On December 17, the Henlius Global R&D Day event was held in Shanghai
.
The detailed data of the mid-term analysis of the ASTRUM-005 study was announced at the meeting .

The ASTRUM-005 study is a randomized, double-blind, international multi-center, phase III clinical study that evaluated slulimumab and placebo combined with chemotherapy for the treatment of previously untreated extensive-stage small cell lung cancer (ES-SCLC) Patient effectiveness and safety
.

As of October 22, 2021, a total of 585 patients were enrolled in the ASTRUM-005 study, and the median follow-up time was 12.
3 months
.

The median overall survival (OS) of the slulimumab group (n=389) and the placebo group (n=196) were 15.
38 months and 11.
10 months, respectively (HR 0.
62, 95% CI 0.
48-0.
80, p <0.
001), and the 2-year OS stock rates were 43.
2% and 8.
0%, respectively
.

In the Asian population, the median OS of the slulimumab group and the placebo group were 16.
03 months and 11.
10 months, respectively (HR 0.
59, 95% CI 0.
44-0.
79, p<0.
001)
.

The test results show that slulimumab combined with carboplatin-etoposide can significantly improve the OS of first-line ES-SCLC patients, and has good safety
.

02JAMA: Apatinib can further benefit PFS and OS in RAIR-DTC patients! The prognosis of patients with radioactive iodine refractory differentiated thyroid cancer (RAIR-DTC) is poor, and the treatment options for it are relatively limited
.

The REALITY study is a phase III randomized clinical study that evaluated the efficacy and safety of apatinib, a highly selective vascular endothelial growth factor 2 (VEGFR-2) inhibitor, in the treatment of progressive locally advanced or metastatic RAIR-DTC
.

The study included 92 patients with locally advanced or metastatic RAIR-DTC.
The patients were randomly assigned (1:1) to take apatinib (500 mg/d) or placebo, and the study allowed those who received placebo treatment to progress The patient switched to taking apatinib for treatment
.

The primary endpoint of the study is the PFS assessed by the investigator
.

Secondary endpoints include OS, objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to onset of response, and safety
.

The results of the study showed that after a median follow-up of 18.
1 months (IQR: 12.
7-22.
2), the median PFS of patients in the apatinib group was 22.
2 months (95% CI 10.
91-not reached), patients in the placebo group The median PFS was 4.
5 months (95%CI 1.
94-9.
17; HR 0.
26, 95%CI 0.
14-0.
47, p<0.
001)
.

The median OS of the two groups of patients was not reached (95%CI 26.
25-not reached) and 29.
9 months (95%CI 18.
96-not reached; HR 0.
42, 95%CI 0.
18-0.
97, p=0.
04)
.

The ORR of patients in the apatinib group was 54.
3% (95% CI 39.
0%-69.
1%), the DCR was 95.
7% (95% CI 85.
2%-99.
5%), and the ORR of patients in the placebo group was 2.
2% (95% CI 0.
1%) -11.
5%), the DCR is 58.
7% (95% CI 43.
2%-73.
0%)
.

The most common treatment-related adverse events above grade 3 in the apatinib group were hypertension [16 (34.
8%)], hand-foot syndrome [8 (17.
4%)], proteinuria [7 (15.
2%)] and diarrhea [7 (15.
2%)], and no such adverse events occurred in the placebo group
.

The results of the study show that for RAIR-DTC patients, apatinib can prolong the benefits of PFS and OS with controllable safety
.

03New drug: oral small molecule PD-L1 inhibitors are approved for clinical use! Recently, Arnold Pharma announced that its original innovative drug, the oral PD-L1 inhibitor AN4005, has been approved by the National Medical Products Administration (NMPA) for drug clinical trials.
It will start an open, multi-center, phase I treatment for patients with advanced cancer in China.
Research
.

In pre-clinical studies, AN4005 has shown good anti-tumor activity as well as good druggability and safety
.

As of now, there is no approved or marketed PD-(L)1 small molecule inhibitor in the world.
AN4005 is expected to become the world's first small molecule PD-(L)1 inhibitor to be marketed
.

04New drugs: Two domestically produced generic lenvatinibs have been approved for marketing! Recently, the NMPA official website approval document shows that the lenvatinib mesylate capsules of Osaikang Pharmaceutical and Kelun Pharmaceutical have been approved for marketing
.

Lenvatinib is a first-line targeted therapy for liver cancer.
In the medical insurance negotiations in December 2020, the price of lenvatinib was reduced by 80% and entered the medical insurance catalog.
The implementation began in March this year.
Its latest bid price was 108 yuan/ 4mg, the burden on patients has been reduced.
Since the end of July, domestic generic drugs have been approved successively, which will further benefit patients
.

Currently, lenvatinib has been approved for 8 companies
.

References: [1]https://mp.
weixin.
qq.
com/s/QzWyxhUsjHURVAHhQuM9-g[2]Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine–Refractory Differentiated Thyroid Cancer: The REALITY Randomized Clinical Trial https://jamanetwork.
com/journals/jamaoncology/fullarticle/2786815[3]https://mp.
weixin.
qq.
com/s/OXQ8HHRQJLrZE16nTmaxMA[4]https://mp.
weixin.
qq.
com/s/ FbOX0ALN--f2QEUCPb3-FQ