1.Tilelizumab’s second-line or third-line treatment of non-small cell lung cancer Phase III RATIONALE 303 trial reached its primary clinical endpoint.
On November 17, BeiGene announced the interim analysis data of the phase III trial RATIONALE 303 of tislelizumab. RATIONALE303 is a global multi-center, randomized, open-label Phase III study designed to evaluate the efficacy and safety of tislelizumab and docetaxel in the second or third-line treatment of patients with locally advanced or metastatic NSCLC. 805 patients from 10 countries who had previously received platinum-containing chemotherapy participated in this trial. The results of the study showed that in the intent-to-treat population (ITT), tislelizumab listed docetaxel significantly prolonged overall survival (OS), reached the main clinical endpoint of the trial phase.
2. Pfizer released detailed data of the Phase III CROWN trial of loratinib for the first-line treatment of ALK-positive NSCLC.
On November 19, Pfizer announced the CROWN data of the phase III trial of loratinib for the first-line treatment of ALK+NSCLC. CROWN is a global, randomized, open-label, parallel, two-arm trial that enrolled 296 patients who had not previously received treatment and were randomized to receive loratinib or crizotinib monotherapy. The results of the study showed that the proportion of patients who received lauratinib vs. crizotinib treatment for 12 months without disease progression (PFS) was 78% vs. 39% (HR, 0.28), and the ORR was 76% vs. 58%. The ORR of patients with brain metastases was 82% vs. 23%. The incidence of grade 3/4 adverse events was 72% vs. 56%, and the rate of discontinuation due to adverse events was 7% vs. 9%.
3. Amgen announced the Phase I clinical results of anti-CD3/DLL3 dual anti-AMG 757 in the treatment of small cell lung cancer.
On November 9, Amgen announced the data of the Phase I proof-of-concept trial of AMG 757 in the treatment of r/r small cell lung cancer. The phase I study evaluating the safety, tolerability, and pharmacokinetics of AMG757 in patients with small cell lung cancer included 40 patients. In the end, 38 patients could be evaluated, and 6 patients achieved partial responses, that is, 16% achieved PR and 29% achieved SD. Cytokine release syndrome (CRS) was observed in 43% of patients, and no interruption or suspension of treatment was observed.
4. Cinda announces detailed data of the Phase III ORIENT-32 trial of Sintilizumab/bevacizumab for first-line treatment of hepatocellular carcinoma.
On November 22, Cinda Biopharmaceutical announced the clinical research results of ORIENT-32 at the 2020 European Society of Medical Oncology Asia Annual Meeting (ESMO-ASIA) online meeting in the form of a preferred oral report. ORIENT-32 is a randomized, open-label, multi-center clinical phase III study, enrolling a total of 571 patients, randomly enrolled according to 2:1, receiving sintilizumab/bevacizumab or sorafil, respectively Ni for treatment. The final results showed that the median OS of the Sintilizumab/bevacizumab group and Sorafenib group were not reached and 10.4 months respectively. Compared with Sorafenib, the median OS of Sintilizumab/bevacizumab group was 10.4 months. The risk of death in the Vallizumab group was reduced by 43.1% (HR 0.569); the median PFS was 4.6 vs 2.8 months (HR 0.565).
5. The Phase II FIGHT trial of Bemarituzumab for the first-line treatment of gastric cancer reached the primary clinical endpoint.
On November 10th, Five Prime announced the top-line data of the first-line treatment of FGFR2b+/non HER2+ advanced gastric cancer/gastroesophageal junction cancer phase II trial FIGHT with bemarituzumab. FIGHT trial enrolled 155 patients with gastric cancer/gastric junction cancer. The results of the study showed that the median PFS of bemarituzumab+mFOLFOX6 vs. placebo+mFOLFOX6 was 9.5 months vs. 7.4 months (HR 0.68, p=0.073), and the median OS was NR vs. 12.9 months (HR 0.58, p=0.027) ), ORR was 46.8% vs. 33.3%. The trial reached the preset primary endpoint. The incidence of adverse events of all grades in the experimental group and the control group was equivalent (100% vs. 98.7%).
Renal cell carcinomas
6. The Phase III KEYNOTE-581/CLEAR trial of pembrolizumab/lenvatinib for the first-line treatment of renal cell carcinoma reached the primary clinical endpoint.
On November 10, MSD and Eisai announced the top-line data of the key phase III trial KEYNOTE-581/CLEAR of pembrolizumab combined with lenvatinib for the first-line treatment of advanced renal cell carcinoma. KEYNOTE-581 is a global multi-center, randomized, open-label phase III study involving a total of 959 patients. The trial protocol is pembrolizumab / lenvatinib vs Lenvatinib / everolimus vs. Nitinib. The test results showed that: in the ITT population, pembrolizumab + lenvatinib significantly improved PFS, OS and ORR compared with sunitinib. The trial reached the primary and key secondary endpoints. Compared with sunitinib, lenvatinib+everolimus also achieved the primary and key secondary endpoints of improving PFS and ORR.
7. TG Therapeutics announced the detailed data of the Phase III UNITY-CLL trial of umbralisib/ublituximab in the treatment of chronic lymphocytic leukemia.
On November 4, TG Therapeutics announced the detailed data of Phase II UNITY-NHL trial. The ORR of umbralisib monotherapy for marginal zone lymphoma (MZL) subgroup reached 49.3%, and the ORR of follicular lymphoma (FL) subgroup was 45.3. %.The Phase III UNITY-CLL trial announced on the same day included 421 patients with chronic lymphocytic leukemia (CLL), of which 57% were newly treated and 43% were relapsed or refractory, with a median follow-up of 36.2 months, a new generation of PI3Kδ inhibitors The PFS of the new CD20 monoclonal antibody combination (umbralisib+ublituximab) vs. otuzumab + chlorambucil was 31.9 months vs. 17.9 months, and the ORR was 83.3% vs. 68.7%. For newly treated patients, the median PFS was 38.5 vs 26.1 months (HR 0.482); for relapsed or refractory patients, the median PFS was 19.5 vs 12.9 months (HR 0.601).
8. The phase III IMCgp100-202 trial of Tebentafusp for the first-line treatment of uveal melanoma reached the primary clinical endpoint.
On November 23, Immunocore announced the data of the phase III trial IMCgp100-202 of tebentafusp. IMCgp100-202 is a randomized, multicenter, open-label Phase II study to evaluate the safety and effectiveness of Tebentafusp in the first-line treatment of metastatic uveal melanoma. A total of 378 patients were enrolled in the trial. The trial protocol was tebentafusp vs. optional therapy (82% chose pembrolizumab). The results of the study showed that in the ITT patient group, the 1-year OS rate of tebentafusp vs. the investigator’s choice of therapy was respectively It is 73% vs. 58%, and the hazard ratio is 0.51.
9. The Phase III SEAL trial of Selinexor in the treatment of dedifferentiated liposarcoma reached the primary clinical endpoint.
On November 2, Karyopharm Therapeutics announced that the selinexor (XPOVIO, ATG-010) phase III SEAL study reached the primary endpoint. SEAL is a randomized, double-blind, placebo-controlled crossover study to evaluate the efficacy and safety of selinexor in patients with unresectable advanced dedifferentiated liposarcoma who have previously received at least second-line treatment. Approximately 57 patients were enrolled in the phase II study (1:1 randomization), and approximately 285 patients were enrolled in the phase III study (randomized 2:1) and received selinexor and placebo treatments. The final clinical results showed that the median PFS of selinexor and placebo groups was 2.83 vs 2.07 months (HR 0.70), and the median overall survival was 9.99 vs 9.07 months (HR 0.69), reaching the pre-specified primary clinical endpoint of the trial.
10. Kangfang Biology announces preliminary clinical data of AK112 and cadonilimab.
On November 3, Kangfang Biological announced the preliminary clinical data of AK112 and cadonilimab. AK112 is an anti-PD1/VEGF-A bispecific antibody. The phase Ia clinical enrollment of 11 patients with solid tumors who are not sensitive to PD1 inhibitors or who have received PD1 inhibitor treatment has an ORR of 36%. Cadonilimab is an anti-PD1/CTLA4 bispecific antibody. In clinical trials for the treatment of cervical cancer, the ORR reached 47.6%, which is higher than the data of PD1 single agent or PD1/CTLA4 combination.
11. Wanchun announced the top-line data of the Phase III PROTECTIVE-2 trial of Pranabrin to prevent neutropenia (CIN) caused by chemotherapy.
On November 16, Wanchun Medicine announced the top-line data of the registered Phase III PROTECTIVE-2 trial of Pranabrin combined with Pefigrastim to prevent neutropenia caused by chemotherapy. PROTECTIVE-2 is a double-blind international multi-center phase III study, enrolling a total of 221 patients, and the trial protocol is prinabulin/pefigrastim vs pegfigrastim. The results of the study showed that the proportion of patients who did not develop grade 4 neutropenia during the first chemotherapy cycle of pefilgrastim + TAC vs. Pefilgrastim was 31.5% vs. 13.6%, respectively, The trial reached the main clinical endpoint.