Major clinical progress of global new tumor drugs April 2021

Article source: Med

According to incomplete statistics of public information, as of April 30, 2021, NextPharma has included a total of 8 recent major clinical advances in new drugs in the global oncology field.

Lung cancer

1.

In terms of secondary research endpoints, the primary pathological remission (MPR) was also significantly improved, respectively, 36.

Up to now, treatments based on nivolumab have achieved positive results in phase 3 clinical trials of four types of early cancers including NSCLC, esophageal cancer/gastroesophageal junction cancer, bladder cancer and melanoma.

2.

Studies have shown that the median OS of tislelizumab and docetaxel in the ITT population was 17.

This is the first domestically-developed anti-PD-1 monoclonal antibody that has achieved a successful Phase 3 trial in the second-line/third-line treatment of NSCLC.

3.

The results of the study showed that berzosertib+topotecan confirmed an ORR of 36%, and 68.

Lurbinectedin is the first second-line therapy for small cell lung cancer approved since 1996.

4.

TPX-0046 is a new generation of RET inhibitor with high activity against various RET abnormalities, including resistance mediated by solvent frontier mutations, so it is also effective for patients treated with RET-TKI.

Esophageal cancer

5.
CheckMate-648, a phase 3 trial of nivolumab for the first-line treatment of esophageal squamous cell carcinoma, reached the primary and secondary clinical endpoints

On April 8, BMS announced that the Phase III clinical study code-named CheckMate -648 had achieved positive results.
The study enrolled 939 patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
The trial protocol was nivoliumab + chemotherapy vs.
nivoliumab + ipilimumab vs.
chemotherapy.

The results of the planned interim analysis showed that compared with chemotherapy, nivolumab + chemotherapy or ipilimumab combination therapy significantly improved the overall survival (OS) and progression-free survival of PD-L1-positive patients (PFS), the primary endpoint was reached.

In August last year, the CheckMate-649 study, which evaluated nivolumab plus chemotherapy or ipilimumab in the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma, also reached its primary endpoint.

The positive results of these two clinical studies have made nivolumab the first and only first-line treatment in upper gastrointestinal cancers of different histology and tumor sites (gastric, gastroesophageal junction and esophagus).
Superior PD-1/L1 inhibitor.

6.
The first-line treatment of esophageal squamous cell carcinoma with teriprizumab, the phase 3 trial JUPITER-06, reached the primary study endpoint

On April 22, Junshi issued an announcement stating that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (JUPITER) in the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (JUPITER) -06) Reach the main research endpoints (progression-free survival and overall survival) and achieve the pre-specified superiority standard.

Teriplizumab is the first domestic monoclonal antibody drug targeting PD-1 approved for marketing in China.
So far, it has been approved for the treatment of 3 types of tumors, namely melanoma, nasopharyngeal carcinoma and urinary tract cancer.
Skin cancer.

Renal cell carcinoma

7.
Pembrolizumab is used in the key phase 3 trial of adjuvant treatment of renal cell carcinoma after nephrectomy, KEYNOTE-564 reaches the primary clinical endpoint of DFS

On April 8, Merck announced that the phase III clinical study of pembrolizumab as a single-agent adjuvant treatment of patients undergoing nephrectomy or metastatic lesion resection of renal cell carcinoma (RCC) reached the primary endpoint.
This is the first positive result of anti-PD-1 therapy in adjuvant treatment of renal cell carcinoma patients.

According to an interim analysis conducted by the Independent Data Monitoring Committee, compared with placebo, patients receiving pembrolizumab monotherapy had statistically significant and clinically significant improvements in disease-free survival (DFS).
The study will continue to evaluate whether pembrolizumab can reach the key secondary endpoint of prolonging the patient's OS.
It is worth noting that pembrolizumab combined with axitinib for the first-line treatment of advanced RCC indications has been approved in the United States, Europe and Japan.

Blood tumor

8.
BeiGene announced the interim data of the Phase 3 trial ALPINE for the treatment of R/R CLL/SLL compared with zebutinib head-to-head.

On April 28, 2021, BeiGene issued an announcement announcing that Zebutinib was compared with ibrutinib in the treatment of relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) The patient's Phase 3 head-to-head clinical trial (ALPINE) obtained positive results in the interim analysis.

Zebutinib reached the primary endpoint of the above trial, that is, the non-inferiority objective response rate (ORR; p value <0.
0001) evaluated by the investigator and the Independent Review Committee (IRC).
The investigator evaluated that compared with ibrutinib, zebutinib achieved ORR superiority, and the difference was statistically significant (p value=0.
0006); after IRC evaluation, zebutinib achieved a higher ORR (p Value=0.
0121, but compared with the strict bilateral statistical boundary p value <0.
0099 preset in the interim analysis, it failed to reach statistical significance).
At the same time, the clinical trial reached the safety-related pre-set secondary endpoints.