Research and development . . 2020 Lung Cancer Major Research Exchange...

In the blink of an eye, 2020 is an extraordinary year, this year many academic conferences held online for the first time, but this has not stopped the enthusiasm of researchers and medical personnel, the field of lung cancer ushered in a data explosion disclosure, brought about a global academic boom.
in order to facilitate everyone to learn, the author of this year's lung cancer field of heavy research, I hope to help you.
, the New England Journal of Medicine (NEJM) published the results of the ADAURA III study, which attracted the attention of experts in the field of lung cancer worldwide.
The study was a randomized double-blind, global, placebo-controlled Phase III clinical study designed to assess the efficacy and safety of Aoxini (n-339) and placebo-assisted therapy (3 years) after surgical complete removal in patients with EGFR-sensitive mutations in the IB-IIIA phase±
main endpoint was the researchers' assessment of disease-free survival (DFS) in patients with stage II-IIIA.
results showed that in 470 patients with stage II-IIIA, the two groups of DFS had a medium follow-up time of 22.1 months and 14.9 months, respectively, compared with placebo, and that those with stage II-IIIA were The mid-DFS was significantly extended, with the two groups not reaching and 19.6 months (P<0.001, HR-0.17), respectively, reducing the risk of disease recurrence or death by 83%.
total population (IB-IIIA, 682 cases), the mid-DFS in the Oghitini group was also significantly better than the placebo group, at 27.5 months (HR-0.20, P<0.001).
2-year DFS rate was 89% vs 52% respectively in the two groups. Subgroup analysis showed that oxytiniry-assisted therapy could bring significant benefits to patients with different characteristics.
significant DFS benefits were found in all phased patients, with phase IIIA patients benefiting the most, with DFS HR at 0.12.
, regardless of whether or not assisted chemotherapy was used, benefited from follow-up assisted oxytini, with DFS HR reaching 0.16 for patients who had previously received complementary chemotherapy.
In the general population, 7 per cent (23/339) and 18 per cent (61/343) of patients in the Oxitini and placebo groups had local relapses (local recurrence only) and 4 per cent (14/339) and 28 per cent (96/343) patients (only distant or distant with local recurrences), respectively.
two groups, 2% and 11% of patients had a recurrence or death of central nervous system (CNS)-related diseases, and 1% and 10% of patients had a recurrence of CNS, respectively.
two groups, the 24-month survival rate for patients without CNS-related diseases was 98% and 85% (HR-0.18), suggesting that Oghithini reduced the risk of recurrence or death of CNS disease by 82%, and that the mid-CNS disease-free survival in both groups was less than and 48.2 months, respectively.
, in clinical practice, patients with stage II-IIIA EGFR mutations can be recommended as an auxiliary treatment after surgery.
ALEX research ALK target has "diamond mutation", this year, the second and third generation ALK-TKI have made a lot of heavy progress.
, the second generation of APK-TKI Aledini this year published the results of the five-year OS study of ALEX.
ALEX study is a global multi-center, randomized, open-label Phase III. study that compares head-to-head the efficacy of alethinib and cloptonyl in the first-line treatment of patients with late-stage ALK-positive NSCLC.
results showed that the mid-level follow-up time in the Aleitini and clotinist groups was 37.8 months and 23.0 months, respectively, and the main endpoint analysis: the researchers assessed the medium PFS as 34.8 months (95% CI:17.7 months to NR) and 10.9 months, respectively. (95% CI: 9.1 months to 12.9 months), the Alethini group reduced the risk of disease progress or death by 57% (HR -0.43, 95% CI: 0.32 to 0.58; P<0.0001).
53.3 percent of patients in the aletonys group had disease progression events, while 80.8 percent in the cloptonyl group.
subgroup analysis showed that for patients with baseline combined CNS transfers, the medium PFS in the alethinib group (n-64) and quetolineic group (n-58) was 25.4 months and 7.4 months(HR=0.37,95%CI) 0.23 to 0.58), and for patients without CNS transfer at baseline, the two groups of mid-PFS were 38.6 months and 14.8 months( HR s 0.46, 95% CI: 0.31 to 0.68), respectively.
Regardless of whether patients had baseline brain metastasis, there were more patients in the alethinitic group who did not develop the disease than in the clotinist group, 46.4% of patients did not develop the disease in 3 years, and only 13.5% of patients in the closinist group did not have disease progression in 3 years.
OS data for both groups were still immature, the Aletini group had a 31% lower risk of death (HR-0.69, 95% CI: 0.47-1.02) compared to the clotinist group.
for patients with CNS metastasis at the baseline, the alethini group reduced the risk of death by 40% (HR-0.60, 95% CI: 0.34-1.05); In patients with no CNS transfer at baseline, the alethinib group also had an advantage, reducing the risk of death by 23% (HR-0.77, 95% CI:0.45-1.32).
the OS rate in
4 years, the Aletini group was as high as 64.5% (95% CI: 55.6% to 73.4%), while the kerazine group was 52.2% (95% CI: 42.6% to 64.8%).
that although OS data is still immature, it can be seen that Aledini has the tendency to extend OS.
ASCEND series of studies has established the irreplaceable position of ceretinib in APK pathline therapy, and also reveals the story of the inextricable correlation between different dose administration and side effects and drug efficacy.
ASCEND-1 as an open-label Phase I study, Ceredigione was approved by the FDA for the clinical study, which was approved at a dose of 750 mg QD on an empty stomach.
notable for finding in ASCEND-1 that Ceredigion is more effective in Asian populations, which is associated with higher blood concentrations in Asian populations.
despite the encouraging results, the gastrointestinal adverse reactions caused by taking 750mg QD on an empty stomach are still a huge challenge.
a large proportion of Ceredigion subjects experienced treatment-related adverse events during clinical trials.
the way the drug is given on a 750 mg empty stomach leads to poor tolerance to the drug, can the adverse reactions be controlled by dose adjustment? The ASCEND-8 clinical trial provides the answer.
ascend-8 study head-to-head compared the efficacy and safety of the Ceretini 450mg follow-up group and the 750mg ancilation group.
results showed that the 450mg follow-up group had similar drug metabolic dynamics and blood drug concentrations compared to the 750mg fasting oral group, compared with the gastrointestinal tract taken with ceritinium 450 mg The overall incidence of adverse reactions is low, severe diarrhea, nausea, vomiting and other symptoms almost disappeared, and the need to adjust the dose or interruption of drugs significantly reduced, the therapeutic effect is significantly better than the previous 750 mg standard treatment model, the use of new methods of administration after the patient benefit more obviously.
Immunotherapy KEYNOTE-024 Study KEYNOTE-024 study was designed to assess the effectiveness and safety of advanced NSCLC primary patients with platinum-containing chemotherapy therapy PD-L1 TPS≥50%, EGFR, mesolytic lymphoma kinase (ALK)-driven gene mutations selected by the researchers.
study included 305 patients from 16 countries, and was randomly divided into the Pabliju monodrip drug treatment group (200 mg Q3W) and chemotherapy group 1:1.
the disease progressed in patients in the chemotherapy group and were crossed to the Paboliju monoantigen anti-treatment group.
end point of the study is progress-free survival (PFS), and the secondary endpoint is OS, objective mitigation rate (ORR), and security.
as of June 1, 2020, after five years of long follow-up, Pabliju monoantigen resistance still shows better OS and longer-lasting benefits than chemotherapy.
Although nearly 66% of patients in the chemotherapy group received follow-up PD-1/PD-L1 inhibitor treatment (55% of patients in the chemotherapy group crossed to Pabliju monoantigen), the five-year OS rate in the Pabli pearl monoantigen group nearly doubled compared to the chemotherapy group (31.9% to 16.3%). The medium OS is 26.3 (28.3-40.4) months to 13.4 (9.4-18.3) months and HR 0.62 (95% CI, 0.48-0.81).
PFS rate was 5 times higher in the chemotherapy group (22.8% to 4.1%), with a medium PFS of 7.7 (6.1-10.2) months to 5.5 (4.2-6.2) months, and HR 0.50 (95% CI, 0.39-0.65).
39 patients in the
Paboliju monodring group completed 2 years and 35 cycles of treatment, with ORR of up to 82% (32/81, 4 cases of complete remission (CR), 28 cases of partial remission (PR), and 3 years of OS with a rate of 81%.
treatment of associated adverse reactions was significantly lower than that of the chemotherapy group (76.6% to 90%), and no new adverse reactions were found after long follow-up.
KEYNOTE-024 was the first Phase III study to report on the efficacy of late NSCLC first-line immunotherapy for 5 years, and after 5 years of follow-up, it continued to support the effective first-line treatment of PD-L1 TPS≥50% of patients with late NSCLC.
IMpower150 study, IMpower150, is the first Phase III clinical trial of immunotherapy combined with anti-angiogenesic drugs, confirming the efficacy of PD-L1 monoanti-anti-vascular and chemotherapy.
The trial included patients with advanced NSCLC who had not received chemotherapy, and was divided into atili-pearl monoanti-chemotherapy (Group A), atili-pearl monoanti-beval-monoanti-chemotherapy (Group B) and Beval-Pearl monoanti-chemotherapy (Group C).
results showed that the athilite-beval-bead mono-chemotherapy group successfully extended the medium PFS to 8.3 vs 6.8 months (HR 0.6) compared to the chemotherapy-beval-bead mono-anti-chemotherapy group. 2, P<0.001), the combined group also extended the mid-OS (19.5 vs. 14.7 months, HR 0.80, P=0.01).
updated the latest data on the EGFR mutation subgroup at this year's ESMO Conference.
results showed that in EGFR-positive patients, Group B extended the mid-OS (29.4 vs. 18.1 months, HR 0.60) compared to Group C.
addition, in the liver metastasis subgroup, Group B also extended the mid-OS (13.2 vs. 9.1 months, HR 0.67) compared to Group C.
means that immune and antivascular and chemotherapy can benefit patients with EGFR mutations and liver metastasis.
CheckMate-227 study CheckMate-227 is the first and longest-followed joint study of double immunology in the first-line treatment of advanced non-small cell lung cancer, and its three-year follow-up data have many bright spots.
CheckMate 227 is a randomized controlled, open phase III clinical study, the main purpose of which is to compare the efficacy and safety of platinum-containing dual-drug chemotherapy, single-drug Narvulyu monoanti, navuliyu monoantigen, navuliyu mono-drug chemotherapy in late primary treatment or recurrence of NSCLC.
results from Asian populations presented at this year's ESMO conference, the three-year OS rate for PD-L1-positive people using dual-immune first-line therapy reached a high of 53%, and the mid-OS had not yet reached.
in the general population (not layered by PD-L1), the three-year OS rate for dual immunotherapy in the Asian population was 51%, higher than in the overall population (34%).
in asian populations, orR, DOR and PFS for dual immunotherapy all benefit.
Previously, we thought it was unlikely that patients with advanced NSCLC would be able to do "de-chemotherapy", but with the checkMate-227 results announced, some patients had already achieved "de-chemotherapy" treatment on the first line.
RATIONALE 307 Study RATIONALE 307 study is an open, multi-center randomized Phase III clinical trial designed to evaluate the effectiveness and safety of the first-line treatment in patients with late-stage scaly NSCLC in combination with traditional chemotherapy regimens (yew alcohol/albumin yew alcohol and carptonin) in patients with terratin monoantigen (200mg Q3w).
study included 360 patients and randomly assigned to groups A, B and C for different treatments at 1:1:1.
the medium follow-up time was 8.6 months (95% CI: 8.1, 9.0), of which 57 patients in Group A were terminated, 52 in Group B and all patients in Group C (117) were terminated.
distribution of baseline characteristics was balanced across three groups of patients.
as of December 6, 2019, the medium PFS in both Group A and Group B was 7.6 months, significantly higher than the 5.5 months in the chemotherapy group alone; 01) and 0.48 (P.lt;0.0001), which meant that treatment in groups A and B using the combination chemotherapy programme of Terelliju monotherapy significantly reduced the patient's risk of disease progressity by 48% and 52%, respectively, compared to the chemotherapy group alone.
the study also conducted a subgroup analysis of PFS in the PD-L1 subgroup, and the results showed that the improvement of PFS in patients was independent of the expression level of PD-L1.
the results of this key Phase III study, which is used as a late-stage scale for relliju single anti-combination chemotherapy