The impact of PD-L1 on survival and values of nivolumab, atezolizumab, and pembrolizumab compared with docetaxel in second-line non-small cell lung cancer.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 141-141
Author(s):  
Helmy M. Guirgis
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Death Receptor ◽  
Small Cell ◽  
Small Cell Lung ◽  
Check Point Inhibitors ◽  
One Year ◽  
The Impact

141 Background: The impact of programmed death receptor-ligand1 (PD-L1) on values of the immune check point inhibitors (ICPI) has received minimal attention. Objectives: Grade survival and weigh values of Nivolumab (Nivo), Atezolizumab (Atezo) and Pembrolizumab (Pembro) vs. Docetaxel (Doc) in 2nd-line non-squamous non-small-cell lung cancer (NSCLC). Methods: Previously reported median overall survival (OS), adverse events and prices posted by the parent companies were utilized. The OS gains in days over controls were graded (gr) from A to D. Docetaxel costs x 6 -12 cycles and ICPI x one year were calculated separately from adverse events treatment costs (AEsTC). Costs/life-year gain (C/LYG) were computed as drug C/OS gain x 360. Relative Values were expressed as $100,000/C/LYG. Results: Docetaxel costs of 9 cycles were $35,802, OS/gr 87/C, AEs gr ¾ > 20%, AEsTC $4,940 and C/LYG $148,146. Nivo, Atezo and Pembro gr ¾ < 20% were at $1,480 costs. In non-squamous NSCLC, Nivo OS/gr were 84/C and C/LYG $545,754. The results improved in PD-L1 > 10% to 264/A and $177,645 respectively. Atezolizumab demonstrated OS/gr 99/C and C/LYG $551,407 improving in PD-L1 50% to 348/A and $151,193. Pembrolizumab in PD-L1 > 1.0%, the OS/gr were 57/C and C/LYG $659,059 improving in > 50% to 201/A and $186,897. PD-L1 enrichment increased relative values of Nivo from 0.19 to 0.56, Atezo from 0.19 to 0.66 and Pembro from 0.15 to 0.53. Conclusions: In 2nd-line non-squamous NSCLC, the OS of Doc, Nivo, Atezo and Pembro were limited. In PD-L1 enriched, the ICPI resulted in unprecedented OS, improved grades and enhanced values at justifiable costs.

Costs of Extended Use of the Immune Check Point Inhibitors in 1st-line Non-Small Cell Lung Cancer

2021 ◽  
Author(s):  
Helmy M Guirgis
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Check Point ◽  
Small Cell Lung ◽  
Curative Intent ◽  
Check Point Inhibitors ◽  
One Year ◽  
The Impact

Aim: Cost-effectiveness in the health care system has been extensively investigated. Reports, however, on costs and the impact of extended use of the immune check point inhibitors (ICI) are rare. Pembrolizumab (Pembro) improved the 5-year overall survival in1st-line advanced/metastatic non-small cell lung cancer a/m-NSCLC. ICI are rather expensive, and costs are bound to increase with prolonged therapy. We purposed to focus on cost of extended ICI use beyond their indications in a/m-NSCLC. Methods: The 2020 annual posted drug costs were calculated in US$. Except for the one-year adjuvant Durv, used for curative intent, ICI costs were calculated for 2-years and beyond. Adverse events-treatment costs and generic chemo-drugs were not included. Results: ICI costs ranged from $103,400 to $168,948 with $148,431 mean. Adjuvant Durv one-year costs were $148,013. The 2-year Pembro costs in PD-L1 > 50% were $334,652, multiplying to >$836,630 after 5 years. Addition of 4 Peme cycles improved outcome regardless of PD-L1 at costs of $360,912. Costs of the 2-year Atezolizumab/Bevacizumab (Atezo/Bev) and one-year Peme were $722,977. Use of Biosimilar (Bio) saved $77,120. Atezo-Peme without Bev reduced costs to $422,725. Costs of Ipilimumab/Nivolumab (Ipi/Nivo) were $544,696. Adding 2 Peme cycles increased costs to $557,826. Extended for 6 months, the 2-year-costs of the 3 ICI combinations increased by 25% of the maintenance ICI. As compared with Pembro-Peme, the 2-year costs of Atezo/Bio-Bev-Peme were 2.00 higher, Atezo-Bio-Bev-Peme 1.79, Atezo-Pem 1.17, Ipi/Nivo 1.51 and Ipi/Nivo-Peme 1.55. The ratios would further separate with extended use beyond 2 years. Conclusions: ICI costs are determined by duration of therapy more than by the posted annual price. Costs of extended use call for guidance on therapy duration and emphasize the need for cost constraint-policies.

scholarly journals Gefitinib Versus Placebo in Completely Resected Non–Small-Cell Lung Cancer: Results of the NCIC CTG BR19 Study

2013 ◽  
Vol 31 (27) ◽  
pp. 3320-3326 ◽  
Author(s):  
Glenwood D. Goss ◽  
Chris O'Callaghan ◽  
Ian Lorimer ◽  
Ming-Sound Tsao ◽  
Gregory A. Masters ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Postoperative Radiotherapy ◽  
Disease Free Survival ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
The Impact

Purpose Survival of patients with completely resected non–small-cell lung cancer (NSCLC) is unsatisfactory, and in 2002, the benefit of adjuvant chemotherapy was not established. This phase III study assessed the impact of postoperative adjuvant gefitinib on overall survival (OS). Patients and Methods Patients with completely resected (stage IB, II, or IIIA) NSCLC stratified by stage, histology, sex, postoperative radiotherapy, and chemotherapy were randomly assigned (1:1) to receive gefitinib 250 mg per day or placebo for 2 years. Study end points were OS, disease-free survival (DFS), and toxicity. Results As a result of early closure, 503 of 1,242 planned patients were randomly assigned (251 to gefitinib and 252 to placebo). Baseline factors were balanced between the arms. With a median of 4.7 years of follow-up (range, 0.1 to 6.3 years), there was no difference in OS (hazard ratio [HR], 1.24; 95% CI, 0.94 to 1.64; P = .14) or DFS (HR, 1.22; 95% CI, 0.93 to 1.61; P = .15) between the arms. Exploratory analyses demonstrated no DFS (HR, 1.28; 95% CI, 0.92 to 1.76; P = .14) or OS benefit (HR, 1.24; 95% CI, 0.90 to 1.71; P = .18) from gefitinib for 344 patients with epidermal growth factor receptor (EGFR) wild-type tumors. Similarly, there was no DFS (HR, 1.84; 95% CI, 0.44 to 7.73; P = .395) or OS benefit (HR, 3.16; 95% CI, 0.61 to 16.45; P = .15) from gefitinib for the 15 patients with EGFR mutation-positive tumors. Adverse events were those expected with an EGFR inhibitor. Serious adverse events occurred in ≤ 5% of patients, except infection, fatigue, and pain. One patient in each arm had fatal pneumonitis. Conclusion Although the trial closed prematurely and definitive statements regarding the efficacy of adjuvant gefitinib cannot be made, these results indicate that it is unlikely to be of benefit.

scholarly journals Immune Check Point Inhibitors and Immune-Related Adverse Events in Small Cell Lung Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Wanting Hou ◽  
Xiaohan Zhou ◽  
Cheng Yi ◽  
Hong Zhu
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Check Point ◽  
Small Cell Lung ◽  
Immune Microenvironment ◽  
Malignant Solid Tumor ◽  
Check Point Inhibitors

Small cell lung cancer (SCLC) is a malignant solid tumor. In recent years, although immune check point inhibitors (ICIs) have achieved important advances in the treatment of SCLC, immune-related adverse events (irAEs) have occurred at the same time during the therapeutic period. Some irAEs lead to dose reduction or treatment rejection. The immune microenvironment of SCLC is complicated, therefore, understanding irAEs associated with ICIs is of great importance and necessity for the clinical management of SCLC. However, the lack of comprehensive understanding of irAEs in patients with SCLC remains remarkable. This review aims to provide an up-to-date overview of ICIs and their associated irAEs in patients with SCLC based on present clinical data.

Costs and values of the immune check point inhibitors antibodies in non-small cell lung cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20644-e20644
Author(s):  
Helmy M. Guirgis ◽  
Corey J. Langer
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Check Point ◽  
Small Cell Lung ◽  
Probability Of Survival ◽  
Life Year Gain ◽  
Check Point Inhibitors ◽  
One Year

e20644 Background: Costs (C) and values (V) of the check point inhibitors antibodies have not been compared. Our objectives were to weigh and compare C and V of Nivolumab (Nivo), Atezolizumab (Atezo) and Pembrolizumab (Pembro) vs. Docetaxel (Doc) in 2nd-line non-small-cell lung cancer (NSCLC). Methods: Median overall survival gain over control (OS), hazard ratios (HR), doses and prices posted by parent companies were quoted. Probability of survival (PoS) was calculated as (1.0- HR). Values were computed at 4-week (w) as 4wC/PoS and one-year as C/life-year gain (LYG). Results: Doc OS was 72 days, HR not reported, generic 4wC < $500 and C/LYG 26,896. In comparison, in non-enriched non-squamous (sq-) Nivo C/LYG was 558,313, Atezo 618,244, Pembro 659,059. Nivo OS was 84, HR 0.73, 4wC $10,021 and 4wV 37,115 improving in > 10% PD-L1 positive to OS 264, HR 0.27 and 4wV 13,727. Atezo OS was 87, HR 0.73, 4wC $11,493 and 4wV 42,567 improving in medium- high PD-L1 to 150, 0.46 and 4wV 21,283 respectively. Pembro demonstrated OS 57, HR 0.71, 4wC $8,027 and 4wV 27,679 improving in > 50% PD-L1 to 201, 0.54 and 4wV 17,450. Conclusions: Doc, without accounting for adverse events and quality of life, remains a valuable drug in 2nd-line NSCLC. In PD-L1- enriched non-sq, Nivo, Atezo and Pembro consistently demonstrated marked V improvement to justify their C. The limited available data and the inherent problems of drug comparison preclude favoring one ICPIA over another. References: Doc: Shepherd FA et al. JCO 18:2095, 2000; Nivo: Checkmate 057, Brahmer JN et al. NEJM 373: 123, 2015; Atezo: POPLAR; Pembro: KEYNOTE-010.

scholarly journals The Impact of Immune-related Adverse Events on the Effect of Immune Checkpoint Inhibitors in Non-small Cell Lung Cancer

Haigan ◽  
2019 ◽  
Vol 59 (2) ◽  
pp. 128-136
Author(s):  
Keiko Tanimura ◽  
Tadaaki Yamada ◽  
Yusuke Chihara ◽  
Yutaka Kubota ◽  
Shinsuke Shiotsu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Small Cell ◽  
Small Cell Lung ◽  
The Impact

Efficacy and Safety of Antigen-specific Immunotherapy in the Treatment of Patients with Non-small-cell Lung Cancer: A Systematic Review and Meta-analysis

2019 ◽  
Vol 19 (3) ◽  
pp. 199-209 ◽  
Author(s):  
Bing-Di Yan ◽  
Xiao-Feng Cong ◽  
Sha-Sha Zhao ◽  
Meng Ren ◽  
Zi-Ling Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Systematic Review ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Specific Immunotherapy ◽  
Meta Analysis ◽  
Small Cell ◽  
Efficacy And Safety ◽  
Small Cell Lung

Background and Objective: We performed this systematic review and meta-analysis to assess the efficacy and safety of antigen-specific immunotherapy (Belagenpumatucel-L, MAGE-A3, L-BLP25, and TG4010) in the treatment of patients with non-small-cell lung cancer (NSCLC). </P><P> Methods: A comprehensive literature search on PubMed, Embase, and Web of Science was conducted. Eligible studies were clinical trials of patients with NSCLC who received the antigenspecific immunotherapy. Pooled hazard ratios (HRs) with 95% confidence intervals (95%CIs) were calculated for overall survival (OS), progression-free survival (PFS). Pooled risk ratios (RRs) were calculated for overall response rate (ORR) and the incidence of adverse events. </P><P> Results: In total, six randomized controlled trials (RCTs) with 4,806 patients were included. Pooled results showed that, antigen-specific immunotherapy did not significantly prolong OS (HR=0.92, 95%CI: 0.83, 1.01; P=0.087) and PFS (HR=0.93, 95%CI: 0.85, 1.01; P=0.088), but improved ORR (RR=1.72, 95%CI: 1.11, 2.68; P=0.016). Subgroup analysis based on treatment agents showed that, tecemotide was associated with a significant improvement in OS (HR=0.85, 95%CI: 0.74, 0.99; P=0.03) and PFS (HR=0.70, 95%CI: 0.49, 0.99, P=0.044); TG4010 was associated with an improvement in PFS (HR=0.87, 95%CI: 0.75, 1.00, P=0.058). In addition, NSCLC patients who were treated with antigen-specific immunotherapy exhibited a significantly higher incidence of adverse events than those treated with other treatments (RR=1.11, 95%CI: 1.00, 1.24; P=0.046). </P><P> Conclusion: Our study demonstrated the clinical survival benefits of tecemotide and TG4010 in the treatment of NSCLC. However, these evidence might be limited by potential biases. Therefore, further well-conducted, large-scale RCTs are needed to verify our findings.

Do we Need Maintenance Chemotherapy in Advanced NSCLC in the Era of Immune and Targeted Therapy?

2019 ◽  
Vol 15 (1) ◽  
pp. 50-55
Author(s):  
Ahmed Nagy ◽  
Omar Abdel Rahman ◽  
Heba Abdullah ◽  
Ahmed Negida
Keyword(s):  
Lung Cancer ◽  
Maintenance Therapy ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Statistical Significance ◽  
Small Cell ◽  
Maintenance Chemotherapy ◽  
Small Cell Lung ◽  
The Impact

Background: Although well established for the effective management of hematologic cancers, maintenance chemotherapy has only been recently incorportated as a treatment paradigm for advanced non–small-cell lung cancer. Maintenance chemotherapy aims to prolong a clinically favorable response state achieved after finishing induction therapy which is usually predefined in number before startng treatment. There are 2 modalities for maintenance therapy; continuation maintenance (involving a non-platinum component which was a part of the induction protocol or a targeted agent) and switch maintenance therapy (utilizing a new agent which was not a part of the induction regimen). Methods: The purpose of this article is to review the role of maintenance therapy in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC) and provide a brief overview about induction chemotherapy in NSCLC to address the basis of maintenance therapy as a treatment option. We will also compare the impact of maintenance chemotherapy with the now evolving role of immunotherapy in NSCLC. Results: There have been 4 maintenance studies to date showing prolonged PFS and OS with statistical significance. However, Three out of the four studies (ECOG4599, JMEN, and PARAMOUNT) did not report tumor molecular analysis. As regard Immunotherapy, current data is in favour of strongly an increasing role for immunotherapy in NSCLC. Conclusion: Maintenance therapy in NSCLC continues to be an important therapeutic line to improve outcome in patients with metastatic and recurrent disease.

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