The paper holds the clinical research data of four domestic PD-1 lung cancers

Author . . Cake lung cancer is China's highest incidence and mortality of malignant tumors, non-small cell lung cancer (NSCLC) in lung cancer accounted for about 85% (non-scale cancer accounted for 55%, squamous about 30%), a large group of patients make NSCLC PD-1 single anti-larger adaptive.
manufacturers have laid out clinical studies on lung cancer, especially the first-line treatment of late-stage NSCLC.
incomplete statistics, at least 10 domestic PD-1 inhibitors have entered clinical trials or are about to enter clinical trials.
the efficacy of domestic PD-1 inhibitors in lung cancer? Today, the author for you to summarize the current four domestic PD-1 clinical research data in lung cancer.
Karelli pearl monoantigen resistance 1, Camel research: chemical-free first-line treatment of advanced non-squamous non-small cell lung cancer, PFS/OS double benefit domestic PD-1 inhibitors in non-scale NSCLC research and development is the fastest progress of Karelli Bead monoanti, June 19, 2020, has been officially approved for non-scale NSCLC first-line treatment, the approval of the adaptation certificate is based on a Karelli pearl monoantigen PHASE III clinical study - CameL study.
CameL study aims to explore the effectiveness and safety of carelli's single-anti-combination platinum-containing double-drug chemotherapy (carptonin-pemetroser) as a first-line treatment in patients with late-stage/metastasis non-scale NSCLC who drive gene-negative.
in this Phase III study, a total of 412 NSCLC patients were recruited in China and randomly assigned to a combination or chemotherapy group of Carelli's pearl monoantigen and chemotherapy on a 1:1 scale.
study ends with no progression lifetime (PFS), with secondary endpoints including objective mitigation rate (ORR), disease control rate (DCR), mitigation duration (DoR), and total lifetime (OS).
similar clinical studies abroad, the CameL study data are from China, so the study is of greater significance to Chinese patients.
results showed that carelli-pearl monotherapy significantly extended the patient's medium PFS (11.3 months vs. 8.3 months) and the combined treatment group's ORR (60.0% vs. 39.3) compared to pure chemotherapy. 1%), DCR (87.3% vs. 74.4%), DoR (17.6 months vs. 9.9 months) and OS (less than 20.9 months) were significantly better than patients in the chemotherapy group alone.
these positive results have established the position of carelli pearl monoantigene in the first-line treatment in patients driving gene-negative non-scale NSCLC.
CameL study explores the effectiveness and safety of carelli's monotherapy for non-scale NSCLC, while in the field of lung scale cancer, several studies have confirmed the good performance of karelli's monotherapy.
the future, Carelli's monoantigen resistance has a long-awaited prospect in the fields of new auxiliary treatment of local late-stage non-small cell lung cancer, as well as postoperative ancillary treatment and small cell lung cancer.
2, single-drug for second-line treatment, the medium total survival of up to 19.4 months 2019 WCLC, Guangdong Provincial People's Hospital Professor Wu Yilong reported the Karelli Zhu single-drug second-line treatment of late NSCLC Phase II clinical research results.
as of August 1, 2018, a total of 146 patients had been treated with Karelliju monotherapy.
results showed that the ORR (objective mitigation rate) of the ITT (intentional therapy) population was 18.5%, the medium PFS (no progression lifetime) was 3.2 months, and the medium OS was 19.4 months.
subgroup analysis showed that PD-L1 expression was positively related to efficacy, and no disease relief was observed in patients who were positive for EGFR mutations.
, the patient had long-term continuous remission, with a half-DoR (remission duration) of 15.1 months.
in patients with advanced/metastasis NSCLC who had been treated in the past, Karelli-Pearl monoantigen resistance was improved on ORR, PFS, and OS compared to previous studies of second-line chemotherapy.
3, combined chemotherapy remission rate of up to 60%, is expected to become a new treatment for advanced/metastasis non-squamous non-small cell lung cancer treatment program between May 12, 2017 and June 6, 2018, a total of 412 cases of EGFR and ALK-driven gene-negative patients of advanced non-squamous non-small cell lung cancer received treatment, of which 205 patients received Carelli's monothermal monothermal chemotherapy, 207 patients received simple chemotherapy.
results showed that carelli-pearl monoantigen chemotherapy significantly extended the patient's medium PFS to 11.3 months.
, the ORR was as high as 60% in patients in the Karelliju single anti-combination chemotherapy group, significantly better than in patients in the chemotherapy group alone.
studies have shown that the treatment of Karelli-Juju monotherapy has significantly improved the overall survival benefits of lung cancer patients.
Sindili monoantiantORIENT-11: is a randomized, double-blind, Phase III study designed to compare the efficacy of Python and platinum-type combined Cindili monoanti/placebo therapy for locally advanced or metastasis non-scaly NSCLC patients in China.
included 397 untreated localized advanced or metastasis non-scaly NSCLC patients who were not suitable for surgery or topical treatment without EGFR or ALC gene changes.
were randomly assigned to the Syndicate monoanti (n-266) or placebo (n-131) group at 2:1.
study ends with PFS.
secondary endpoints include OS, ORR, DCR, TTR, DoR, and security.
as of November 15, 2019, the mid-range follow-up time is 8.9 months (interval: 0.6-14.8).
227 cases (85.3%) and 105 (80.2%) in the placebo group completed four cycles of induction therapy and received maintenance therapy, the main reasons for the induced suspension of the drug were disease progression, 21 cases (7.9%) in the Syndicate monoantigroup and 13 cases (9.9%) in the placebo group.
PFS in the Syndicate monoantigroup was significantly longer than in the placebo group (8.9 months vs 5.0 months; HR, 0.482, 95% CI, 0.362-0.643; p.lt;0.00001).
68.3 per cent (95 per cent CI, 62.0-73.8) and 42.0 per cent (95 per cent CI, 32.8-50.9) in the placebo group.
HR in patients with brain transfer was 0.578 (95%CI, 0.283-1.180) and HR in patients with brain transfer was 0.468 (95% CI, 0.342-0.641).
orR in the Syndicate monoantigroup was 51.9% (95% CI, 45.7-58.0) significantly higher than the 29.8% (95% CI, 22.1-33.4) in the placebo group (P-0.0. 00003), DCR was 86.8% (95% CI, 82.1-99.7) and 75.6% (95% CI, 67.3-82.7) in the Xindili monoantigroup.
DoR in the Syndicate monoantigroup has not yet been reached (95% CI, 8.0-NR), while the placebo group has 5.5 months (95% CI, 4.1-10.9).
TTR was 1.5 months (interval, 1.2-7.0) and the placebo group was 2.6 months (interval, 1.2-5.1).
The clinical efficacy and safety of the first-line treatment of patients with advanced lung cancer in China in the first-line treatment of the single-stage multi-queue clinical study of the phase II.
four queues are targeted at different pathological types or treatment options.
: As of June 30, 2019, all 54 patients included were analyzed.
non-scale cancer queue ORR is 44%, the medium PFS 9 months, the medium OS has not yet reached, the scale cancer-A queue ORR is 80%, the medium PFS 7 months, the medium OS has not yet reached, the SQ-B queue ORR is 67%, the medium PFS and OS have not yet reached, the SCLC queue ORR is 77%, the medium PFS 6.9 months, the middle OS is 15.6 months.
RATIONALE 307:307 Study is an open, multicenter randomized Phase III clinical trial designed to assess the effectiveness and safety of first-line therapy in patients with violet mellow plus platinum or albumin-yew alcohol plus carbalin in patients with rellipolytin monoantigen (200mg given every 3 weeks).
the clinical design of the study is unique in that it is a three-arm trial, with chemotherapy (yew alcohol and carptonin) as the control group, and two other test groups were set up, namely, Terelli pearl monoantigen and sequoia plus carptonin, and tyrelli pearl monoantigen and albumin yew alcohol and carptonin.
study included 360 Chinese patients, who were asseded to a 1:1:1 ratio.
results showed that in the PFS, mPFS in the reilly-pearl monoantigen-albumin-carptonin group was 7.6 months, the risk of disease progressity was reduced by 52%, mPFS in the reilly-pearl monoantigen-sequoia-carptonin group was reduced by 7.6 months, and the risk of disease progressity was reduced by 48% in the chemotherapy control group mPFS was 5.5 months.
In ORR, the ORR of the reilly bead monoantigen-albumin-carpol-carptonic group was 74.8%, the orR of the reilly-pearl monoanti-eucalypse-carptonin group was 72.5%, and the chemotherapy control group was 49.6%.
In the DoR area, mDoR in the reilly bead monoantigen-albumin-carpul group was 8.6 months, the mDoR in the reilly-pearl monoanti-fir-carpul group was 8.2 months, and the chemotherapy control group was 4.2 months.
Ripley monoantigen CT18: This is a Phase II, multi-center, open-label, one-arm study.
study included 40 patients who had previously failed to receive EGFR TKI treatment without T790M mutation or EGFR activation mutation with failure to receive oghithinib treatment, receiving 240 mg or 360 mg Fixed doses of Tripri monoanti (Q3W) combined with carpton and pyrethroids 4 to 6 cycles, followed by Terripri monoantigen pyrethroids maintenance therapy until the disease progresses (PD) or is not resistant to toxicity.
study ends with ORR.
results: Data as of July 25, 2019, 40 patients in the whole group were assessed, with 50% orR confirmed (95% CI: 33.8% to 66.2%), 20 patient partial remission (PR), and 15 patients with stable disease (SD; including 1 unrefired PR) ), the disease control rate (DCR) was 87.5% (95% CI: 73.2% to 95.8%), the medium DoR: 7.0 months, and the middle PFS for the overall population was 7.0 months (95% CI: 4.8 months to 10.3 months).
four major domestic PD-1, in the field of lung cancer treatment efficacy does not lose imports, for the national medicine cheer, look forward to the rise of more domestic new drugs.
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