June 29, 2022

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2021 ASCO: 9 PD-1/L1 Inhibitors for Lung Cancer updated

2021 ASCO: 9 PD-1/L1 Inhibitors for Lung Cancer updated

 

2021 ASCO: 9 PD-1/L1 Inhibitors for Lung Cancer updated.    The 2021 American Society of Clinical Oncology (ASCO) Annual Meeting-Virtual Conference will be held on June 4-8, 2021. Today, the relevant abstracts of thoracic tumors are freshly released. This article has compiled relevant research on lung cancer immunotherapy, let us have a quick glance Right!

 

 


01  Navulumab

CheckMate-9LA follow-up for 2 years. Results update: Comparing Nivolumab (NIVO) + Ipilimumab (IPI) + 2 cycles of chemotherapy (chemotherapy) and chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC) ( 4 cycles) first-line treatment (Abstract: 9000)

 

Research Background

In the randomized Phase 3 CheckMate-9LA trial (NCT03215706), compared with chemotherapy alone (4 cycles), first-line nivolumab + ipilimumab combined with 2 cycles of chemotherapy significantly improved overall survival (OS) , Progression-free survival (PFS) and objective response rate (ORR). Regardless of PD-L1 expression level and histology, clinical benefits were observed. Here, we report the data of at least 2 years of follow-up in this study.

 

Research method

According to PD-L1 (<1%vs≥1%), gender and histology (squamous vs non-squamous) ECOG performance status ≤1 and no known sensitizing EGFR/ALK mutation stage IV/recurrent NSCLC Adult patients were stratified and randomly assigned to the nivolumab 360 mg Q3W + ipilimumab 1 mg/kg Q6W + chemotherapy group (2 cycles; n=361) or chemotherapy alone (4 cycles) at a 1:1 ratio ; N=358). Non-squamous NSCLC patients in the chemotherapy single-agent group can receive pemetrexed maintenance treatment. The primary endpoint is OS. Secondary endpoints included PFS and ORR assessed by a blinded independent center review and the efficacy of different PD-L1 levels. Security is exploratory.

 

Research result

When OS was followed up for at least 24.4 months (database lock: February 18, 2021), patients receiving nivolumab + ipilimumab + chemotherapy continued to obtain OS benefits compared with chemotherapy, with a median OS They were 15.8 months vs 11.0 months (HR, 0.72 [95%CI, 0.61-0.86]); the 2-year OS rate was 38% vs 26%, respectively. The median PFS of nivolumumab + ipilimumab + chemotherapy and chemotherapy was 6.7 months vs 5.3 months (HR, 0.67 [95% CI, 0.56-0.79]); 8% and 37% of Patients with disease progression received follow-up immunotherapy. The ORR of the nivolumab+ipilimumab+chemotherapy group was 38%, and that of the chemotherapy group was 25%. The clinical benefits of nivolumab + ipilimumab + chemotherapy were similar to those of chemotherapy, including PD-L1 expression level or histology, were observed in all randomized patients and most subgroups. 92% and 48% of patients in the nivolumab+ipilimumab+chemotherapy group reported treatment-related adverse events of any grade and 3-4, compared with 88% and 38% of the chemotherapy group, respectively.

 

Analysis conclusion

The shortest follow-up time is 2 years. Among patients with advanced NSCLC, first-line nivolumab + ipilimumab + chemotherapy showed long-lasting survival and benefit compared with chemotherapy; no new safety signals were found. Clinical trial information: NCT03215706

 

 


02  Pembrolizumab


KEYNOTE-799: A phase 2 trial of pembrolizumab combined with platinum-based chemotherapy and radiotherapy for the treatment of unresectable, locally advanced stage 3 NSCLC. (Abstract: 8512)

 

Research Background

KEYNOTE-799 (NCT03631784) is an ongoing study of anti-PD-1 antibody pembrolizumab (pembro) combined with concurrent chemoradiotherapy (cCRT) in the treatment of unresectable, locally advanced stage III NSCLC patients. Previous results obtained in this study in a subset of patients (primary efficacy population) showed that the ORRs of cohort A (squamous and non-squamous, n=112) and cohort B (non-squamous, n=61) were 69.6 respectively % And 70.5%, the incidence of non-infectious pneumonia ≥3 grade was 8.0% and 7.9%, respectively. Here, we introduce the results of all patients enrolled in KEYNOTE-799.

 

Research method

This non-randomized, multicenter, open-label, phase II trial enrolled patients with stage IIIA-C NSCLC who were ≥18 years of age and were previously untreated, unresectable, and pathologically confirmed. These patients have measurable measures according to RECISTv1.1 disease. Patients in cohort A (squamous and non-squamous) received 1 cycle of carboplatin AUC 6 and paclitaxel 200 mg/m2 and pembrolizumab 200 mg. After 3 weeks, the patient received carboplatin AUC 2 and paclitaxel 45mg/m2QW for 6 weeks and 2 cycles of pembrolizumab 200mg Q3W plus standard chest radiotherapy (TRT). Patients in cohort B (non-squamous cell carcinoma only) received 3 cycles of cisplatin 75mg/m2, pemetrexed 500mg/m2, and pembrolizumab 200mg Q3W treatment, and in cycles 2 and 3 Accept TRT. All patients received another 14 cycles of Pembrolizumab 200mg Q3W treatment. The primary endpoint was the incidence of ORR determined by Blind Independent Center Review (BICR) according to RECISTv1.1 and pneumonia ≥ Grade 3 (according to NCICTCAEv4.0). Evaluate efficacy and safety in all patients receiving treatment.

 

Research result

Among the 216 patients enrolled in KEYNOTE-799 (cohort A, n=112; cohort B, n=104), 112 patients in cohort A and 102 patients in cohort B received treatment. As of October 28, 2020, the median (range) time from the first administration to the database cutoff for cohort A was 18.5 (13.6-23.8) months, and cohort B was 13.7 (2.9-23.5) months. The ORR (95%CI) of cohort A was 70.5% (61.2%-78.8%), and cohort B was 70.6% (60.7%-79.2%). Neither cohort reached the median DOR. ORR is similar, regardless of PD-L1 status ([TPS<1% and TPS≥1%]; cohort A, 66.7% and 75.8%; cohort B, 71.4% and 72.5%) and tumor histology (cohort A, squamous Cell carcinoma, 71.2% and non-squamous cell carcinoma, 69.2%). Nine patients (8.0%) in cohort A and 7 patients (6.9%) in cohort B developed grade ≥3 non-infectious pneumonia. 72 patients (64.3%) in cohort A and 51 patients (50.0%) in cohort B had grade 3-5 treatment-related AEs.

 

Analysis conclusion

Regardless of PD-L1 TPS and tumor histology, pembrolizumab+cCRT still shows good anti-tumor activity. In previously untreated patients with locally advanced stage III NSCLC, the follow-up time is longer and the safety is manageable . Clinical trial information: NCT03631784

2021 ASCO: 9 PD-1/L1 Inhibitors for Lung Cancer updated

 

 

 


03  Atelizumab

A pooled analysis of immune-related adverse events (irAE) and efficacy of the phase III trials IMpower130, IMpower132 and IMpower150. (Abstract: 9002)

 

Research Background

PD-L1/PD-1 inhibitors have changed the treatment of advanced NSCLC. There is evidence that the occurrence of irAEs when using these drugs can predict improved outcomes for cancers (such as NSCLC). Atelizumab (atezo; anti-PD-L1) has shown efficacy and tolerability in NSCLC, and has been approved for first-line and second-line treatment. Phase III IMpower130, IMpower132 and IMpower150 trials evaluated atelizumab + chemotherapy ± bevacizumab as the first-line treatment of NSCLC. We explored the correlation between irAE and efficacy in these trials.

 

Research method

Each trial enrolled patients with untreated stage IV non-squamous NSCLC. Patients were randomly assigned to receive: carboplatin+albumin-bound paclitaxel in IMpower130 or combined with atilizumab; carboplatin or cisplatin in IMpower132 or combined with atilizumab; IMpower150 Atelizumab (A) + Bevacizumab (B) + Carboplatin + Paclitaxel (CP), ACP or BCP. Summary data (data deadline: March 15, 2018 [IMpower130]; May 22, 2018 [IMpower132]; September 13, 2019 [IMpower150]), and according to treatment (including atelizumab vs. Control) and irAE status for analysis. The time-dependent Cox model and landmark analysis at 1, 3, 6, and 12 months were used to control immortality bias. The study protocol requires that if irAE (Gr) ≥ grade 3 occurs, atelizumab treatment should be interrupted/stopped.

 

Research result

2503 patients were included in the analysis (atelizumab, n=1577; control, n=926). In the two groups, irAE (atelizumab, n=753; control, n=289) and non-irAE (atifizumab, n=824; control, n=637) were among the patients The baseline characteristics between the two are roughly balanced. 48% (atifizumab) and 32% (control) of patients had any gr irAE; 11% (atifizumab) and 5% (control) had grade 3-5 irAE. The most common irAEs (atelizumab vs. control) were skin rash (28% vs 18%), hepatitis (laboratory abnormalities; 15% vs 10%), and hypothyroidism (12% vs 4%). The median time to the first occurrence of irAE was 1.7 months (atelizumab group) vs 1.4 months (control group). According to the time-dependent Cox model, the OS HR (95% CI) between patients with and without irAE in the atelizumab group was 0.69 (0.60, 0.78), and the control group was 0.82 (0.68, 0.99); excluded; After rash (considered the least specific irAE), OS and HR (95%CI) were 0.75 (0.65, 0.87) and 0.90 (0.71, 1.12), respectively.

OS logo data

2021 ASCO: 9 PD-1/L1 Inhibitors for Lung Cancer updated

 

Analysis conclusion

In this exploratory pooled analysis, according to the time-dependent Cox model and landmark analysis, in the atelizumab-containing treatment group and the control group, the OS of patients with irAE was longer than that of patients without irAE; after excluding the rash This trend still exists in the atelizumab treatment group. The landmark analysis showed that in the atelizumab group, patients with grade 1/2 irAE had the longest OS, and patients with grade ≥3 irAE had the shortest OS, which may be due to treatment interruption/discontinuation. Clinical trial information: NCT02367781; NCT02657434; NCT02366143

 

 


04  Duvalizumab

Elderly patients with unresectable stage 3 non-small cell lung cancer (NSCLC) receiving definitive radiotherapy and chemotherapy with or without duvalizumab: safety and outcome. (Abstract: 8547)

 

Research Background

Recent studies have shown that the addition of valizumab to unresectable stage 3 NSCLC radiotherapy and chemotherapy (CRT) can significantly improve overall survival. In view of the increased toxicity of CRT, the benefit of CRT in elderly patients is considered controversial. Therefore, despite the proven superiority of duvalizumab, the use of duvalizumab in elderly patients may be insufficient after CRT. The practice mode of our center is to provide curative treatment unless clearly contraindicated. We are trying to study the outcome of elderly patients treated with CRT+/- duvalizumab at our center.

 

Research method

The study reviewed all patients with stage 3 NSCLC who received CRT between 2018 and 2020. The patients were analyzed according to age: <70 years old, ≥70 years old. The endpoints of the evaluation are treatment mode, toxicity, progression-free survival (PFS) and overall survival (OS).

 

Research result

We identified 115 patients with stage 3: 44 patients were ≥70 years old (70-89), and 71 patients were younger than 70 years old (34-69). Enrollment criteria: ECOG 0-1 (98%/97%), mean Charlson comorbidity index (CCI) (1.1/0.9) for elderly and young patients; p>0.05. All other baseline characteristics (including PD-L1 expression) are similar. The chemotherapy regimen (platinum combined with etoposide, paclitaxel, or pemetrexed), dose intensity (97% vs 97%), and percentage of planned cycles received (91% vs 96%) were similar. There were 2 deaths related to CRT treatment in the young cohort, and no deaths among the elderly patients. At the completion of CRT, 75% of elderly patients and 72% of young patients were treated with duvalizumab.

Clinician/patient preference is the most common reason (55% vs 25%) for elderly patients not receiving Consolidated Vallizumab. The median time to start dovalizumab treatment for elderly patients was 43 days, and for younger patients was 37 days (p=0.19). Duvalizumab is well tolerated in elderly patients, and the incidence of immune-related adverse events ≥3 is 9%, compared with 6% in young patients; p=0.68. The completion rate of duvalizumab was 30% in elderly patients and 24% in young patients; p=0.22. The median PFS of elderly and young patients was similar (17.9 vs 10.6 months, respectively; p=0.07), even after correction for CCI (HR 0.60; p=0.07). The OS rate was also similar in the two groups (p = 0.93): 77% of elderly patients and 77% of young patients.

 

Analysis conclusion

In elderly patients ≥70 years of age, duvalizumab can be safely administered after definitive CRT with comparable outcomes. The insignificant trend of improvement of PFS in elderly patients indicates that only suitable patients are selected for referral for treatment. In short, all patients should undergo a comprehensive oncology evaluation to determine whether radical treatment can be provided to avoid undertreatment in elderly patients.

 

 


05  Carrelizumab

Carrelizumab (SHR-1210) combined with apatinib with or without stereotactic radiotherapy (SBRT) as a late-line treatment for advanced EGFR-mutant non-small cell lung cancer (NSCLC). (Abstract: e2118)

 

Research Background

Although epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) has achieved significant relief as the first-line treatment of EGFR-mutant NSCLC, the development of drug resistance is inevitable. The application of third-generation EGFR-TKI is increasing, and the mechanism of resistance is still unclear. So far, the best strategy has not been determined after the failure of EGFR-TKI treatment. Several studies have reported that patients with poor efficacy of EGFR-TKI have higher tumor immunogenicity, indicating that they may benefit from immunotherapy. In addition, other studies have shown that apatinib (VEGFR2-TKI) and radiotherapy may enhance the anti-tumor activity of immunotherapy. In this study, we reported the efficacy of carrelizumab plus apatinib with or without SBRT as the first-line treatment of EGFR-mutant NSCLC.

 

Research method

In this one-arm trial, NSCLC patients aged 18-75 years old, who carry EGFR sensitizing mutations, and who have progressed after receiving at least one EGFR-TKI treatment, have not received immunotherapy. All patients received intravenous carrelizumab (200 mg, D1) plus oral apatinib (250 mg daily, administration for 5 days, withdrawal for 2 days), 21 days as a cycle, until the disease progressed or appeared Intolerable toxicity. Some patients have completed SBRT for at least one metastasis site (24-30Gy, 3 times). SBRT is determined by the investigator, and the patient should have at least one unirradiated lesion to monitor the field response. The primary endpoint is progression-free survival (PFS). The secondary endpoints are overall response rate (ORR) and safety.

 

Research result

As of February 1, 2021, 24 eligible patients have been enrolled. 7 patients were excluded due to discontinuation of treatment. Thirteen evaluable patients were included in the efficacy analysis. 1 case received osimertinib, and 3 cases received osimertinib after gefitinib resistance. All patients have received at least first-line chemotherapy after EGFR-TKI resistance. 8 patients received radiotherapy before enrollment. The median follow-up time was 3.5 months (range: 0.7-7.8 months). The median number of cycles is 5 (3-11) PFS, and the OS data is immature. The ORR and disease control rates were 15% (2/13) and 62% (8/13), respectively. 3 cases received SBRT, ORR was no disease progression.

 

Analysis conclusion

Carrelizumab combined with apatinib with or without SBRT as a first-line treatment is beneficial for patients with EGFR-mutant NSCLC. For patients receiving SBRT treatment, this program may have a better effect. It is necessary to investigate further. Clinical trial information: ChiCTR1900028363.

 

 


06  Tilelizumab

RATIONALE-307: Tilelizumab combined with chemotherapy versus chemotherapy alone as the first-line treatment for patients with advanced squamous NSCLC ≥65 years of age. (Abstract: 9102)

 

Research Background

Tilelizumab is a humanized monoclonal antibody with high affinity and specificity for PD-1. It has been confirmed that it has anti-tumor activity in advanced lung cancer. We conducted a phase III, multicenter, randomized, open-label study (NCT03594747) to evaluate the safety and efficacy of tislelizumab plus chemotherapy in patients with advanced squamous NSCLC. As mentioned earlier, tislelizumab (TIS) significantly improves progression-free survival (PFS) and reduces the risk of progression. Here, we report the results of a subgroup of patients ≥65 years of age.

 

Research method

Eligible Chinese patients (aged 18-75 years) are newly treated patients with locally advanced or metastatic squamous NSCLC. The patients were stratified by disease stage (stage IIIB vs. IV) and PD-L1 expression (<1% vs 1-49% vs 50% tumor cells), and randomly assigned to group A at a ratio of 1:1:1 : Tilelizumab 200mg + paclitaxel (P) 175mg/m2 and carboplatin (C) plasma concentration 5 area (once every 3 weeks [Q3W], the first day); Group B: tislelizumab + Albumin-bound paclitaxel (albumin-bound paclitaxel) 100mg/m2 (Q3W+C on day 1, 8 and 15 (Q3W on day 1); Group C: P+C (Q3W on day 1). P, nab- P and C are administered for 4 to 6 cycles. Tislelizumab is administered until the benefit is lost, informed consent is withdrawn, or a new anti-cancer treatment is initiated. In this subgroup analysis, according to the primary endpoint (PFS) and key The secondary endpoints (objective response rate and safety) evaluated patients ≥65 years of age.

 

Research result

Overall, 127 patients ≥65 years of age were randomized to receive treatment. The median age of patients aged ≥65 years was 68.0 years, and 120 patients (94.5%) were men. Overall, 18 (46.2%), 20 (38.5%) and 34 (94.4%) patients in groups A, B, and C discontinued treatment. In group C, 22/34 patients completed chemotherapy. Compared with group C, the primary and secondary endpoints PFS and ORR of group A and group B were longer and higher, respectively. In groups A, B, and C, 33 patients (84.6%), 44 (84.6%), and 28 (82.4%) patients aged ≥65 years had ≥3 treatment-related adverse events (TRAE), respectively. Below, 103 (85.8%), 99 (83.9%) and 94 (80.3%) patients who were enrolled in the study group aged ≥18 years had TRAE. The most commonly reported TRAEs in patients ≥65 years of age were anemia, decreased neutrophil count, and hair loss.

 

Analysis conclusion

In this subgroup analysis, patients with advanced squamous NSCLC aged ≥65 years had longer and higher PFS and ORR, respectively. In patients ≥65 years of age, the safety characteristics of TIS are similar to those of all patients ≥18 years of age. Clinical trial information: NCT03594747

2021 ASCO: 9 PD-1/L1 Inhibitors for Lung Cancer updated

 

 

 


07  Treprizumab

Phase II trial of teriprizumab combined with chemotherapy as a neoadjuvant treatment for resectable stage III non-small cell lung cancer (NeoTPD01 study) (Abstract: 8541)

 

Research Background

Multimodal therapy provides moderate survival benefits for patients with locally advanced non-small cell lung cancer (NSCLC). Preoperative immunotherapy continues to prove promising for the treatment of resectable NSCLC. The purpose of this study was to study the activity and safety of the PD-1 inhibitor teriprizumab combined with chemotherapy as a neoadjuvant therapy for resectable stage III NSCLC in Asian populations.

 

Research method

Recruited eligible patients are ≥18 years old, histologically confirmed as AJCC-defined stage IIIA or T3-4N2 stage IIIB NSCLC, considered to be surgically resectable. Patients receive 3 cycles of intravenous teriprizumab 240 mg, carboplatin and pemetrexed (500 mg/m2 for adenocarcinoma) or albumin-bound paclitaxel (others are 260mg/m2) Neoadjuvant therapy. Surgical resection is performed 4-5 weeks after the first day of the last treatment cycle. The primary endpoint is the primary pathological remission (MPR; ≤10% of surviving tumor cells). Secondary endpoints include pathological complete response (pCR), R0 resection rate, disease-free survival, and safety. Exploratory study of primary tumor +/- lymph nodes and blood samples at baseline and at the time of surgery. This study is registered with ClinicalTrials. gov, NCT04304248.

 

Research result

From August 2019 to July 2020, 33 patients (median age: 61 years, IQR: 56-66; female: 6 cases, 18.2%) were enrolled and received neoadjuvant therapy. Eighteen patients (54.5%) had squamous cell lung cancer, and 13 patients (39.4%) had stage IIIB disease of T3-4N2. Two cases refused surgery, and one case progressed after treatment. Thirty patients (91.9%) underwent resection (median time interval between neoadjuvant therapy and surgery: 36.5 days, IQR30-42.5), except for one patient, all patients achieved R0 resection (29/30, 96.7%). Among the eligible population, 20 patients (20/30, 66.7%) had MPR, including 15 patients (15/30, 50.0%) had pCR.

Surgical complications included 3 cases of arrhythmia, 1 case of persistent air leak, and 1 case of chylothorax. Twenty-four patients (80.0%) were pathologically downgraded after treatment, and 70.0% (21/30) of the patients had complete lymph node clearance (ypN0). The most common grade 3-4 treatment-related adverse event in the intention-to-treat population was anemia (2, [6.0%]). Severe treatment-related adverse events included grade 3 peripheral neuropathy (Guillain-Barré syndrome) in 1 patient (3.0%), which resulted in the cancellation of surgery. At the time of the data cutoff (February 7, 2021), the median follow-up time was 4.13 months, and there were no treatment-related deaths.

 

Analysis conclusion

In patients with resectable stage III NSCLC, the MPR rate of teriprizumab + platinum-containing dual-agent chemotherapy is high, the treatment-related toxicity is controllable, and surgical resection is feasible. The conference will provide ongoing biomarker analysis. Clinical trial information: NCT04304248

 

 


08  Sintilimab

PD-1 monoclonal antibody neoadjuvant therapy can cut non-small cell lung cancer with 2-year follow-up (Abstract: 8522)

 

Research Background

Early-stage non-small cell lung cancer can benefit from PD-1 monotherapy; however, survival characteristics remain to be disclosed. Here, we present the two-year follow-up results of the Phase 1b study of the anti-PD-1 inhibitor Sintilizumab in the neoadjuvant treatment of NSCLC.

 

Research method

Untreated patients with resectable NSCLC (stage IA-IIIB) received 2 cycles of sintilizumab and then undergoing surgical resection. The postoperative sintilimab treatment is at the discretion of the investigator. The primary endpoint is AE, and the key secondary endpoints include primary pathological response (MPR), 1-year and 2-year disease-free survival (DFS) rates, and 2-year overall survival (OS) rates.

 

Research result

Of the 40 patients enrolled, 36 (90%) received R0 resection and were included in the R0 resection population. As of the data cutoff date (January 20, 2021), the median follow-up time for DFS and OS of all enrolled patients was 23.9 (IQR20.5-24.4) months and 26.4 (IQR24.2-29.0) months. A total of 12 patients (33.3%) relapsed and 6 patients died. The 1-year and 2-year DFS rate was 91.7%/73.3%. The 2-year OS rates of the overall population and R0 population were 87.5%/91.7%, respectively. In the R0 resection population, none of them reached the median DFS and OS. A better 2-year DFS rate was observed in patients who achieved MPR (MPR vs non-MPR: 86.7% vs 63.8%). The DFS of patients with non-squamous cell carcinoma was shorter than that of patients with squamous cell carcinoma (HR2.71[95%CI 0.67–11.0], p=0.1479). Compared with patients with TMB<10 and TPS<50, patients with tumor mutation burden (TMB) ≥10 mutations/Mb and PD-L1 tumor proportion score (TPS) ≥50% tend to have a better 2-year DFS rate . For the analysis of post-event free survival (EFS), the same trend of DFS was observed in different subgroups, and the EFS of patients with TMB ≥ 10 mutations/Mb was significantly improved (HR 0.125[95%CI 0.02,1.03], P=0.0222 ).

 

Analysis conclusion

PD-1 monoclonal antibody treatment is a promising neoadjuvant treatment strategy for resectable NSCLC, which can improve clinical outcomes. In this case, MPR can be used as an alternative efficacy biomarker. Clinical trial information: ChiCTR-OIC-17013726.

 

R0 DFS in the resection population

2021 ASCO: 9 PD-1/L1 Inhibitors for Lung Cancer updated

*Assessed by the researcher according to RECISTv1.1

 

 


09  Cemiplimab

EMPOWER-lung 1 subgroup analysis: cemiplimab monotherapy is used as the first-line (1L) treatment for patients with advanced non-small cell lung cancer (NSCLC) brain metastases with PD-L≥50% (Abstract: 9085)

 

Research Background

In the phase III EMPOWER-Lung 1 study, compared with chemotherapy, cemiplimab monotherapy provided significant survival benefits and acceptable safety characteristics for patients with advanced NSCLC with PD-L1≥50%. EMPOWER-Lung 1 included patients with brain metastases who had insufficient baseline in clinical trials. Other published exploratory analyses in single-cohort studies suggest that this patient population can benefit from immunotherapy. Here, we introduce the subgroup analysis of EMPOWER-Lung 1 patients with brain metastases.

 

Research method

The patients were randomized to receive cemiplimab 350mg IV every 3 weeks or chemotherapy (NCT03088540) selected by the investigator at a ratio of 1:1. In the EMPOWER-Lung 1 study, patients with clinically stable brain metastases (not requiring radiological stability) who received treatment in the population with PD-L1≥50% (n=563) were eligible for enrollment, which is the focus of this subgroup analysis.

 

Research result

Of the 563 cases, a total of 68 (12.1%) received treatment for stable brain metastases at the time of randomization. The patients were evenly distributed between cemiplimab (n=34) and chemotherapy (n=34), and the median follow-up duration was similar. Baseline characteristics are usually similar; median (range) age between cemiplimab and chemotherapy group: 60.0 (45-76) vs 62.0 (48-77) years; male: 97.1% vs 85.3%; non-squamous histology: 85.3% vs76.5%. According to the independent review committee, the median overall survival (OS, 18.7 vs 11.7 months), median progression-free survival (PFS, 10.4 vs 5.3 months) and objective response rate (ORR, 41.2% vs 8.8%) in the cemipilimab group ) Is better than the chemotherapy group. After baseline, central nervous system (CNS) disease progression occurred in 2 (5.9%) cemilimab-treated patients and 4 (11.8%) chemotherapy patients; 9 (26.5%) cemilimab-treated patients and 15 (44.1%) chemotherapy patients occurred Disease progression outside the CNS.

 

Analysis conclusion

In patients with advanced NSCLC with PD-L1≥50% and clinically stable brain metastases at baseline, compared with chemotherapy, first-line teriprizumab monotherapy improved OS, PFS, and ORR. Cemiplimab monotherapy is a suitable choice for this subgroup of patients. Clinical trial information: NCT03088540

 

Clinical outcome of patients with advanced NSCLC brain metastases

 



Editor’s note:

In recent years, immunotherapy has become the first choice for patients with advanced NSCLC driven by gene negative.

Regardless of the expression of PD-L1, the long-term survival data brought by first-line immune monotherapy is shocking.

More and more innovative drugs shine in non-squamous cell carcinoma and squamous cell carcinoma. We look forward to more research progress in the future, benefit more patients, and achieve high-quality long-term survival.

 

 

 

(source:internet, reference only)


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