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*Only for medical professionals to read and reference for 1 minute a day, to give you professional "talks" in the tumor circle! (If you need the original text of the literature, you can add the editor's WeChat yxj_oncology to get it) Key Tips 1.
Lancet: Pembrolizumab adjuvant therapy for high-risk stage II melanoma significantly improves recurrence-free survival! KEYNOTE-716 interim analysis data update 2.
JAMA oncol: Pazopanib combined with TRC105 did not improve PFS in patients with advanced angiosarcoma compared with pazopanib alone3.
Frontier: Median OS reached 27.
4 months! Domestic PD-1 monoclonal antibody refreshes the record of immunotherapy combined with chemotherapy in the first-line treatment of advanced squamous cell carcinoma of the lung Second-line treatment of LBCL, CAR-T therapy approved in my country for clinical 01Lancet: Pembrolizumab adjuvant therapy for high-risk stage II melanoma significantly improves recurrence-free survival! Update on Interim Analysis of KEYNOTE-716 Studies have demonstrated that pembrolizumab prolongs progression-free and overall survival (OS) in patients with advanced melanoma, and recurrence-free survival (RFS) in patients with stage III disease after surgical resection )
.
The Lancet published the results of the first and second RFS interim analysis of KEYNOTE-716 evaluating pembrolizumab as adjuvant therapy in patients with completely resected high-risk stage II melanoma
.
Studies have shown that adjuvant pembrolizumab in the treatment of stage IIB or IIC melanoma significantly reduces the risk of disease recurrence or death compared with placebo, with manageable safety
.
Screenshot of study publication KEYNOTE-716 is a double-blind, randomized, placebo-controlled, international, multicenter Phase III study enrolling patients 12 years of age or older with newly diagnosed, completely resected stage IIB or IIC melanoma (TNM stage T3b or T4, negative sentinel lymph node biopsy)
.
Eligible patients were randomly assigned (1:1) and stratified by T stage (3b, 4a, and 4b) and adulthood (age 12-17 years vs ≥18 years)
.
Patients received intravenous pembrolizumab 200 mg (2 mg/kg in juvenile patients) or placebo every 3 weeks for 17 cycles or until disease recurrence or unacceptable toxicity
.
The primary endpoint was the investigator-assessed RFS (defined as the time from randomization to relapse or death) in the intent-to-treat (ITT) population
.
976 patients were randomly assigned to pembrolizumab (n=487) or placebo (n=489)
.
The median age was 61 years (IQR 52-69)
.
At the first interim analysis, 54 (11%) of 487 patients in the pembrolizumab group and 82 (17%) of 489 patients in the placebo group had their first disease recurrence or death (HR = 0.
65 ; 95%CI: 0.
46–0.
92; p=0.
0066)
.
At the second interim analysis, 72 (15%) patients in the pembrolizumab group and 115 (24%) in the placebo group experienced a first relapse or death (HR=0.
61; 95% CI 0.
45-0.
82 )
.
Neither group achieved the median RFS
.
In the first interim analysis, Grade 3-4 treatment-related adverse events occurred in 78 of 483 patients (16%) in the pembrolizumab group and 21 of 486 (4%) in the placebo group event
.
In the first interim analysis, 4 patients died from adverse events, all in the placebo group (1 each from pneumonia, COVID-19-related pneumonia, suicide, and cancer recurrence)
.
In the second interim analysis, 1 additional patient died from an adverse event (COVID-19-associated pneumonia) in the pembrolizumab group
.
No deaths due to treatment occurred
.
02JAMA oncol: Pazopanib combined with TRC105 did not improve PFS in patients with advanced angiosarcoma compared with pazopanib alone.
Angiosarcoma is a rare subtype of sarcoma with a poor prognosis
.
In a phase I/II clinical trial, the median progression-free survival (PFS) of Carotuximab (TRC105) in combination with pazopanib in pazopanib-naïve patients with chemotherapy-refractory angiosarcoma was 7.
8 months
.
Recently, JAMA oncology published the results of the TAPPAS trial, which showed that the combination of pazopanib and TRC105 was not superior to pazopanib monotherapy in patients with advanced hemangiosarcoma
.
Screenshot of study publication The TAPPAS trial is a multinational, multicenter, open-label, phase III trial that enrolled 123 patients with advanced angiosarcoma 18 years of age or older
.
Patients were randomized 1:1 to receive pazopanib ± TRC105
.
Inclusion criteria were no more than two lines of prior systemic therapy and Eastern Cooperative Oncology Group performance status (ECOG) of 0 or 1
.
Patients in the single-agent group received oral pazopanib, 800 mg/d, patients in the combination group received intravenous TRC105 10 mg/kg, administered weekly, plus oral pazopanib 800 mg/d, according to patient tolerance or until disease progression allowed Adjust the dose
.
The primary endpoint was PFS, as assessed by blinded independent radiographic and dermatographic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
1 guidelines
.
Secondary endpoints included objective response rate (ORR) and OS
.
Of the 114 evaluable patients (53 in the monotherapy group and 61 in the combination group), 69 (61%) were female, with a median age of 68 years (range 24-82 years); 57 (50%) With skin disease, 32 (28%) were untreated
.
The primary endpoint of PFS was not met (HR=0.
98; 95% CI: 0.
52-1.
84; P=0.
95), and the median PFS was 4.
3 months (95% CI: 2.
9 months-not met) in the single-agent arm and 4.
3 months in the combination arm was 4.
2 months (95% CI: 2.
8-8.
3 months)
.
The most common all-grade adverse events in the single-agent and combination groups were fatigue (29, 55% vs 37, 61%), headache (12, 23% vs 39, 64%), and diarrhea (27, 51 % vs 35, 57%), nausea (26, 49% vs 29, 48%), vomiting (12, 23% vs 23, 38%), anemia (5, 9% vs 27, 44%), epistaxis (2 cases, 4% vs 34 cases, 56%), hypertension (29 cases, 55% vs 22 cases, 36%)
.
03 Frontier: Median OS reached 27.
4 months! On March 31, Hengrui Medicine announced that at the 2022 European Lung Cancer Conference (ELCC) being held, Zhou Caicun of Shanghai Pulmonary Hospital affiliated to Tongji University The professor orally reported the latest OS data of the CameL-sq study: the median OS of the camelizumab combined with chemotherapy group was 27.
4 months, which was nearly 1 year longer than that of the chemotherapy group (15.
5 months), and the 3-year OS rate was 42.
8%
.
Hengrui Medicine pointed out in a press release that the CameL-sq study has refreshed the current median OS record of a phase III randomized controlled trial of immunotherapy combined with chemotherapy in the first-line treatment of advanced lung squamous cell carcinoma, and camrelizumab combined with chemotherapy has created a new survival rate.
Data height (including median OS and 3-year OS rate), bringing new breakthroughs to the field
.
The CameL-sq study is a Chinese multicenter, double-blind, randomized controlled phase III trial comparing camrelizumab or placebo combined with carboplatin and paclitaxel, respectively, in first-line treatment of stage IIIB-IV squamous non-small cell lung cancer (NSCLC).
clinical research
.
As of January 31, 2022, the median follow-up of the camrelizumab plus chemotherapy group and chemotherapy group was 23.
7 months and 15.
2 months, respectively
.
Compared with chemotherapy, camrelizumab plus chemotherapy increased median OS by nearly 1 year (27.
4 months vs.
15.
5 months) and significantly reduced the risk of death by 43%; both 2- and 3-year survival rates were higher About 20% in the chemotherapy-only group (53.
4% vs.
35.
0%, 42.
8% vs.
23.
7%)
.
At the same time, the updated safety data showed that no new safety signals were observed, and the incidence of adverse events during treatment and treatment-related adverse events were comparable between the two groups
.
04New drug: first-line treatment of NSCLC, the world's first PD-L1/CTLA-4 dual antibody The first phase III clinical trial reached the preset endpoint On March 31, Corning & Jereh announced that its self-developed PD-L1/CTLA-4 dual antibody The first phase III clinical study of KN046 completed the first interim analysis and reached the preset endpoint
.
Based on this result, Corning Jereh will submit a new drug application for KN046 for this indication as planned, that is, in combination with chemotherapy as a first-line treatment for squamous NSCLC
.
This time, KN046 achieved the prespecified endpoint in a multicenter, randomized, double-blind, placebo-controlled phase III clinical study (ENREACH-LUNG) in combination with platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous NSCLC.
-01)
.
The results showed that KN046 combined with platinum-based chemotherapy, compared with placebo combined with platinum-based chemotherapy, achieved a significant and clinically meaningful prolongation of PFS in patients with advanced squamous NSCLC, meeting the preset superiority criteria
.
The safety profile is consistent with the previously reported results of KN046-related clinical studies, and no new safety signals have emerged
.
05New drugs: Second-line treatment of LBCL, CAR-T therapy approved for clinical trials in China On March 31, WuXi Junuo announced that its Ruiqiorenza injection was approved for a phase III clinical trial for second-line treatment of large B-cell lymphoma
.
Ruiki Orenza injection is an autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product targeting CD19, which has been approved in China for relapsed or refractory large B-cell lymphoma ( third-line therapy for patients with LBCL)
.
Screenshot of CDE's official website The approved study (JWCAR029-010 study) is a multi-center, randomized controlled, open-label Phase III clinical study in China, aiming to use first-line drugs (anthracyclines and rituximab) The efficacy and safety of the drug were evaluated in adult subjects with relapsed or refractory LBCL who did not achieve complete remission (CR) or within 12 months of complete remission after treatment with monoclonal antibody or other CD20-targeted drugs
.
Reference: [1].
Jason J Luke, et al.
Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial.
The Lancet Journal.
Published :March 31, 2022DOI:https://doi.
org/10.
1016/S0140-6736(22)00562-1https:// fulltext[2].
Jones RL, et al.
Efficacy and Safety of TRC105 Plus Pazopanib vs Pazopanib Alone for Treatment of Patients With Advanced Angiosarcoma: A Randomized Clinical Trial.
JAMA Oncol.
2022 Mar 31.
doi: 10.
1001/jamaoncol.
2021.
3547.
Epub ahead of print.
PMID: 35357396.
https://jamanetwork.
com/journals/jamaoncology/fullarticle/2790727[3].
https://mp.
weixin.
qq.
com/s/AcJ-Z9DrVfJ8bxyMbWWNeA[4].
https: //mp.
weixin.
qq.
com/s/Lq0_zis8SRPnh34XoDc_SQ[5].
https://mp.
weixin.
qq.
com/s/tif-RaSEVENEbszKqZ4C1A
Lancet: Pembrolizumab adjuvant therapy for high-risk stage II melanoma significantly improves recurrence-free survival! KEYNOTE-716 interim analysis data update 2.
JAMA oncol: Pazopanib combined with TRC105 did not improve PFS in patients with advanced angiosarcoma compared with pazopanib alone3.
Frontier: Median OS reached 27.
4 months! Domestic PD-1 monoclonal antibody refreshes the record of immunotherapy combined with chemotherapy in the first-line treatment of advanced squamous cell carcinoma of the lung Second-line treatment of LBCL, CAR-T therapy approved in my country for clinical 01Lancet: Pembrolizumab adjuvant therapy for high-risk stage II melanoma significantly improves recurrence-free survival! Update on Interim Analysis of KEYNOTE-716 Studies have demonstrated that pembrolizumab prolongs progression-free and overall survival (OS) in patients with advanced melanoma, and recurrence-free survival (RFS) in patients with stage III disease after surgical resection )
.
The Lancet published the results of the first and second RFS interim analysis of KEYNOTE-716 evaluating pembrolizumab as adjuvant therapy in patients with completely resected high-risk stage II melanoma
.
Studies have shown that adjuvant pembrolizumab in the treatment of stage IIB or IIC melanoma significantly reduces the risk of disease recurrence or death compared with placebo, with manageable safety
.
Screenshot of study publication KEYNOTE-716 is a double-blind, randomized, placebo-controlled, international, multicenter Phase III study enrolling patients 12 years of age or older with newly diagnosed, completely resected stage IIB or IIC melanoma (TNM stage T3b or T4, negative sentinel lymph node biopsy)
.
Eligible patients were randomly assigned (1:1) and stratified by T stage (3b, 4a, and 4b) and adulthood (age 12-17 years vs ≥18 years)
.
Patients received intravenous pembrolizumab 200 mg (2 mg/kg in juvenile patients) or placebo every 3 weeks for 17 cycles or until disease recurrence or unacceptable toxicity
.
The primary endpoint was the investigator-assessed RFS (defined as the time from randomization to relapse or death) in the intent-to-treat (ITT) population
.
976 patients were randomly assigned to pembrolizumab (n=487) or placebo (n=489)
.
The median age was 61 years (IQR 52-69)
.
At the first interim analysis, 54 (11%) of 487 patients in the pembrolizumab group and 82 (17%) of 489 patients in the placebo group had their first disease recurrence or death (HR = 0.
65 ; 95%CI: 0.
46–0.
92; p=0.
0066)
.
At the second interim analysis, 72 (15%) patients in the pembrolizumab group and 115 (24%) in the placebo group experienced a first relapse or death (HR=0.
61; 95% CI 0.
45-0.
82 )
.
Neither group achieved the median RFS
.
In the first interim analysis, Grade 3-4 treatment-related adverse events occurred in 78 of 483 patients (16%) in the pembrolizumab group and 21 of 486 (4%) in the placebo group event
.
In the first interim analysis, 4 patients died from adverse events, all in the placebo group (1 each from pneumonia, COVID-19-related pneumonia, suicide, and cancer recurrence)
.
In the second interim analysis, 1 additional patient died from an adverse event (COVID-19-associated pneumonia) in the pembrolizumab group
.
No deaths due to treatment occurred
.
02JAMA oncol: Pazopanib combined with TRC105 did not improve PFS in patients with advanced angiosarcoma compared with pazopanib alone.
Angiosarcoma is a rare subtype of sarcoma with a poor prognosis
.
In a phase I/II clinical trial, the median progression-free survival (PFS) of Carotuximab (TRC105) in combination with pazopanib in pazopanib-naïve patients with chemotherapy-refractory angiosarcoma was 7.
8 months
.
Recently, JAMA oncology published the results of the TAPPAS trial, which showed that the combination of pazopanib and TRC105 was not superior to pazopanib monotherapy in patients with advanced hemangiosarcoma
.
Screenshot of study publication The TAPPAS trial is a multinational, multicenter, open-label, phase III trial that enrolled 123 patients with advanced angiosarcoma 18 years of age or older
.
Patients were randomized 1:1 to receive pazopanib ± TRC105
.
Inclusion criteria were no more than two lines of prior systemic therapy and Eastern Cooperative Oncology Group performance status (ECOG) of 0 or 1
.
Patients in the single-agent group received oral pazopanib, 800 mg/d, patients in the combination group received intravenous TRC105 10 mg/kg, administered weekly, plus oral pazopanib 800 mg/d, according to patient tolerance or until disease progression allowed Adjust the dose
.
The primary endpoint was PFS, as assessed by blinded independent radiographic and dermatographic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
1 guidelines
.
Secondary endpoints included objective response rate (ORR) and OS
.
Of the 114 evaluable patients (53 in the monotherapy group and 61 in the combination group), 69 (61%) were female, with a median age of 68 years (range 24-82 years); 57 (50%) With skin disease, 32 (28%) were untreated
.
The primary endpoint of PFS was not met (HR=0.
98; 95% CI: 0.
52-1.
84; P=0.
95), and the median PFS was 4.
3 months (95% CI: 2.
9 months-not met) in the single-agent arm and 4.
3 months in the combination arm was 4.
2 months (95% CI: 2.
8-8.
3 months)
.
The most common all-grade adverse events in the single-agent and combination groups were fatigue (29, 55% vs 37, 61%), headache (12, 23% vs 39, 64%), and diarrhea (27, 51 % vs 35, 57%), nausea (26, 49% vs 29, 48%), vomiting (12, 23% vs 23, 38%), anemia (5, 9% vs 27, 44%), epistaxis (2 cases, 4% vs 34 cases, 56%), hypertension (29 cases, 55% vs 22 cases, 36%)
.
03 Frontier: Median OS reached 27.
4 months! On March 31, Hengrui Medicine announced that at the 2022 European Lung Cancer Conference (ELCC) being held, Zhou Caicun of Shanghai Pulmonary Hospital affiliated to Tongji University The professor orally reported the latest OS data of the CameL-sq study: the median OS of the camelizumab combined with chemotherapy group was 27.
4 months, which was nearly 1 year longer than that of the chemotherapy group (15.
5 months), and the 3-year OS rate was 42.
8%
.
Hengrui Medicine pointed out in a press release that the CameL-sq study has refreshed the current median OS record of a phase III randomized controlled trial of immunotherapy combined with chemotherapy in the first-line treatment of advanced lung squamous cell carcinoma, and camrelizumab combined with chemotherapy has created a new survival rate.
Data height (including median OS and 3-year OS rate), bringing new breakthroughs to the field
.
The CameL-sq study is a Chinese multicenter, double-blind, randomized controlled phase III trial comparing camrelizumab or placebo combined with carboplatin and paclitaxel, respectively, in first-line treatment of stage IIIB-IV squamous non-small cell lung cancer (NSCLC).
clinical research
.
As of January 31, 2022, the median follow-up of the camrelizumab plus chemotherapy group and chemotherapy group was 23.
7 months and 15.
2 months, respectively
.
Compared with chemotherapy, camrelizumab plus chemotherapy increased median OS by nearly 1 year (27.
4 months vs.
15.
5 months) and significantly reduced the risk of death by 43%; both 2- and 3-year survival rates were higher About 20% in the chemotherapy-only group (53.
4% vs.
35.
0%, 42.
8% vs.
23.
7%)
.
At the same time, the updated safety data showed that no new safety signals were observed, and the incidence of adverse events during treatment and treatment-related adverse events were comparable between the two groups
.
04New drug: first-line treatment of NSCLC, the world's first PD-L1/CTLA-4 dual antibody The first phase III clinical trial reached the preset endpoint On March 31, Corning & Jereh announced that its self-developed PD-L1/CTLA-4 dual antibody The first phase III clinical study of KN046 completed the first interim analysis and reached the preset endpoint
.
Based on this result, Corning Jereh will submit a new drug application for KN046 for this indication as planned, that is, in combination with chemotherapy as a first-line treatment for squamous NSCLC
.
This time, KN046 achieved the prespecified endpoint in a multicenter, randomized, double-blind, placebo-controlled phase III clinical study (ENREACH-LUNG) in combination with platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous NSCLC.
-01)
.
The results showed that KN046 combined with platinum-based chemotherapy, compared with placebo combined with platinum-based chemotherapy, achieved a significant and clinically meaningful prolongation of PFS in patients with advanced squamous NSCLC, meeting the preset superiority criteria
.
The safety profile is consistent with the previously reported results of KN046-related clinical studies, and no new safety signals have emerged
.
05New drugs: Second-line treatment of LBCL, CAR-T therapy approved for clinical trials in China On March 31, WuXi Junuo announced that its Ruiqiorenza injection was approved for a phase III clinical trial for second-line treatment of large B-cell lymphoma
.
Ruiki Orenza injection is an autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product targeting CD19, which has been approved in China for relapsed or refractory large B-cell lymphoma ( third-line therapy for patients with LBCL)
.
Screenshot of CDE's official website The approved study (JWCAR029-010 study) is a multi-center, randomized controlled, open-label Phase III clinical study in China, aiming to use first-line drugs (anthracyclines and rituximab) The efficacy and safety of the drug were evaluated in adult subjects with relapsed or refractory LBCL who did not achieve complete remission (CR) or within 12 months of complete remission after treatment with monoclonal antibody or other CD20-targeted drugs
.
Reference: [1].
Jason J Luke, et al.
Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial.
The Lancet Journal.
Published :March 31, 2022DOI:https://doi.
org/10.
1016/S0140-6736(22)00562-1https:// fulltext[2].
Jones RL, et al.
Efficacy and Safety of TRC105 Plus Pazopanib vs Pazopanib Alone for Treatment of Patients With Advanced Angiosarcoma: A Randomized Clinical Trial.
JAMA Oncol.
2022 Mar 31.
doi: 10.
1001/jamaoncol.
2021.
3547.
Epub ahead of print.
PMID: 35357396.
https://jamanetwork.
com/journals/jamaoncology/fullarticle/2790727[3].
https://mp.
weixin.
qq.
com/s/AcJ-Z9DrVfJ8bxyMbWWNeA[4].
https: //mp.
weixin.
qq.
com/s/Lq0_zis8SRPnh34XoDc_SQ[5].
https://mp.
weixin.
qq.
com/s/tif-RaSEVENEbszKqZ4C1A
