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Indication: First-line treatment of adult patients with non–small cell lung cancer (NSCLC) expressing PD-L1 (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK, or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC
CADTH recommends that Libtayo should be reimbursed by public drug plans for the first-line treatment of adult patients with non–small cell lung cancer (NSCLC) expressing programmed death ligand 1 (PD-L1) with a Tumour Proportion Score (TPS) of 50% or greater, as determined by a validated test, with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation, or c-Ros oncogene 1 (ROS-1) aberrations, who have locally advanced NSCLC and who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC if certain conditions are met.
Libtayo should only be covered to treat patients who have metastatic NSCLC or locally advanced NSCLC that cannot be treated with surgery or chemoradiation, whose tumours have high levels of PD-L1 protein, whose tumours do not have abnormal EGFR, ALK, or ROS1 genes, and who have no prior systemic treatment for advanced or metastatic NSCLC.
Libtayo should be prescribed by clinicians with expertise and experience in treating NSCLC and treatment should be supervised and delivered in outpatient specialized oncology clinics. The price of Libtayo should be negotiated so that it does not exceed the cost of treatment with pembrolizumab.
Lung cancer is the most diagnosed cancer and the leading cause of cancer deaths in Canada. It is estimated that in 2021, 29,600 Canadians were diagnosed with lung cancer and 21,000 Canadians died from lung cancer. Approximately 19% of patients in Canada diagnosed with lung cancer survive for at least 5 years. NSCLC accounts for approximately 85% of lung cancer cases in Canada.
Not all patients have a response to currently available first-line treatments for NSCLC and most patients will experience disease progression.
Treatment with Libtayo is expected to cost approximately $11,956 per patient per month.
The CADTH pCODR Expert Review Committee (pERC) recommends that cemiplimab be reimbursed for the first-line treatment of adult patients with non–small cell lung cancer (NSCLC) expressing programmed death ligand 1 (PD-L1) with a Tumour Proportion Score (TPS) of 50% or greater, as determined by a validated test, with no EGFR, ALK, or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC only if the conditions listed in Table 1 are met.
Evidence from a phase III, open-label randomized controlled trial (RCT) demonstrated that treatment with cemiplimab monotherapy resulted in added clinical benefit over platinum-based doublet chemotherapy in patients with stage IIIB, stage IIIC, or stage IV NSCLC who were not candidates for treatment with definitive chemoradiotherapy, whose tumours expressed PD-L1 in at least 50% of tumour cells, with no EGFR, ALK, or ROS1 aberrations, and who had received no prior systemic treatment for their advanced disease. The EMPOWER-Lung 1 trial (N = 710) demonstrated that treatment with cemiplimab monotherapy was associated with a statistically significant and clinically meaningful improvement in overall survival (OS) compared with investigator’s choice of platinum-based doublet chemotherapy (hazard ratio [HR] = 0.68; 95% confidence interval [CI], 0.53 to 0.87; P = 0.0022). The progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR) results were supportive of the OS results. Conclusions regarding health-related quality of life (HRQoL) outcomes could not be drawn from the EMPOWER-Lung 1 trial due to the open-label nature of the trial, lack of statistical testing, and limited sample sizes at later time points, but the results suggested that HRQoL may be maintained or improved with cemiplimab monotherapy and not worse with cemiplimab versus chemotherapy. The adverse event (AE) results from the EMPOWER-Lung 1 trial indicated that cemiplimab was generally well tolerated and pERC considered the AEs to be manageable. Overall, cemiplimab monotherapy meets some of the needs identified by patients as it prolongs survival versus chemotherapy, likely does not have a detrimental effect on HRQoL versus chemotherapy, has a manageable side effect profile, and may provide improved access to immunotherapy in rural communities.
pERC agreed with the clinical experts that on an individual patient basis, chemotherapy alone is not a relevant comparator for cemiplimab because patients typically only receive chemotherapy in the first-line setting if they are ineligible for immunotherapy. Conclusions around comparative efficacy and safety from an indirect treatment comparison (ITC) of cemiplimab monotherapy with ||||||||||||| ||||||||||| submitted by the sponsor could not be drawn due to substantial heterogeneity between trial populations. Based on the EMPOWER-Lung 1 trial results and the similarity in mechanism of action between cemiplimab and pembrolizumab, pERC agreed with the clinical experts and patients that cemiplimab monotherapy is most likely similar to pembrolizumab monotherapy in terms of efficacy and safety.
At the sponsor-submitted price for cemiplimab and publicly listed price for pembrolizumab, cemiplimab was more costly than pembrolizumab and considered similarly effective based on the economic evaluation. As cemiplimab is considered similarly effective as pembrolizumab, the total drug cost of cemiplimab should not exceed the total drug cost of pembrolizumab over the duration of treatment.
Reimbursement Conditions and Reasons.
Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths in Canada. Tobacco smoking, including exposure to second-hand smoke, remains the main cause of lung cancer. The most common symptoms of lung cancer are cough, dyspnea, hemoptysis, and chest pain, and systemic symptoms such as fatigue and weight loss. NSCLC is the most common histological type which accounts for 85% of patients. The overall survival (OS) for patients with NSCLC varies with disease stage. The estimated 5-year survival is 13 to 36% for patients with stage III disease, and only 10% for those with stage IV disease. At the time of diagnosis, the majority of patients with NSCLC are found to have advanced or metastatic disease. For these patients, the goal of treatment is not curative and is focused on improving symptoms and quality of life, delaying disease progression, and extending OS. Treatment decisions are guided by patient-related and disease-related characteristics, including age, Eastern Cooperative Oncology Group (ECOG) performance status (PS), tumour stage, and presence of driver gene alterations, including epidermal growth factor receptor (EGFR) exon 19 deletion and exon 21 L858R mutation, anaplastic lymphoma kinase (ALK) translocation, and c-Ros oncogene 1 (ROS-1) rearrangement. However, gene alterations are detected in a small fraction of patients. Until recently, patients with advanced or metastatic NSCLC without targetable driver mutations were treated with combination chemotherapy regimens, but chemotherapy regimens alone have been widely replaced with programmed cell death 1 (PD1) and PD-L1 checkpoint immunotherapy treatments (as monotherapy or in combination with chemotherapy) in this setting. Pembrolizumab is the only currently funded immunotherapy used as monotherapy in this setting.
Cemiplimab has been approved by Health Canada for the first-line treatment of adult patients with NSCLC expressing PD-L1 in at least 50% of tumour cells (TPS of 50% or greater), as determined by a validated test, with no EGFR, ALK, or ROS1 aberrations, who have locally advanced NSCLC and who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC. Cemiplimab is a PD-1 immune checkpoint inhibitor and is supplied as a concentrate solution (50 mg/mL) for dilution as 250 mg/5mL and 350 mg/7 mL. The recommended dose of cemiplimab is 350 mg administered as an IV infusion over 30 minutes every 3 weeks.
To make their recommendation, the Committee considered the following information:
Most respondents from the Lung Health Foundation input stated that they experienced some symptoms as a result of their lung cancer, including shortness of breath (64%), fatigue (57%), depression (25%), cough (21%), difficulty fighting infection (21%) and chest tightness (14%). Some respondents indicated that the psychosocial effects of having a disease with a poor prognosis was more debilitating than the physical symptoms. Side effects of currently available treatments reported among participants included: fatigue, nausea, vomiting, mood changes, diminished appetite, weight loss, hair loss, anemia, and neuropathy. Respondents reported that they expect the following key outcomes to be improved from any new drug or treatment: stopping or delaying disease progression with minimal side effects, access to treatments that are effective for advanced disease, and the ability to maintain some quality of life while on treatment. The LCC input evaluated respondents’ treatment preferences, with the assumption that patients will have the option to be treated closer to home at local community hospitals with cemiplimab due to its fixed-dosing model. If given the choice between 2 equally efficacious treatment options, 91% of respondents would choose a therapy closer to home as it would provide benefits such as decreased travel time, savings on travel costs, and increased time with family and caregivers. A total of 97% of LCC respondents believed that having access to an additional treatment option closer to home would improve their HRQoL.
The clinical experts consulted by CADTH noted that pembrolizumab is currently the only funded standard of care monotherapy used for the first-line treatment of advanced or metastatic NSCLC in patients with no EGFR, ALK or ROS1 aberrations and with PD-L1 positive tumours (TPS of 50% or greater). Cemiplimab monotherapy in PD-L1 positive (TPS of 50% or greater) NSCLC appears to be another treatment option with a similar mechanism of action in this setting. However, longer follow-up is needed to confirm that efficacy is maintained and similar to other available options. The clinical experts consulted by CADTH indicated that the only predictive marker of response to PD-1 or PD-L1 inhibitors as monotherapy is PD-L1 testing, which is routinely done in all newly diagnosed patients with advanced or metastatic NSCLC. Clinical response (symptom assessment) and radiological surveillance are used to determine whether a patient is responding to treatment in clinical practice. Improvement in survival and quality of life (i.e., less symptoms, higher functional status, or stabilization of symptoms) would be considered a clinically meaningful response to treatment. Treatment response is evaluated clinically at each visit, and radiologically, approximately every 3 to 4 months.
The clinician group noted that the most important goals of any treatment for NSCLC is to improve OS and PFS. Monotherapy immunotherapy also has the additional benefit of avoiding chemotherapy. Patients most likely to benefit from cemiplimab are those with advanced or metastatic NSCLC and tumours having high levels of PD-L1 expression at least 50%. Cemiplimab would be used as monotherapy in first line for these patients and would be an alternative to pembrolizumab monotherapy, pembrolizumab plus platinum-doublet chemotherapy, or the combination of nivolumab-ipilimumab and 2 cycles of platinum-based chemotherapy. It would not be used as an additional therapy to currently available treatment options. In terms of response to treatment, the clinician group noted that the most meaningful response to treatment is the absence of disease progression followed by improvement in disease-related symptoms, which are assessed every 3 months in clinical practice. Disease progression or intolerable side effects were indicated as the primary reasons to discontinue therapy. The clinician group also noted that treatment continuation beyond progression should remain an option as some patients may benefit from continuing treatment beyond RECIST defined progression.
Responses to Questions from the Drug Programs.
The EMPOWER-Lung 1 study is an ongoing randomized, multi-centre, open-label, phase III study of cemiplimab monotherapy versus platinum-based doublet chemotherapy in patients with stage IIIB, stage IIIC, or stage IV NSCLC who were not candidates for treatment with definitive chemoradiotherapy, whose tumours expressed PD-L1 in at least 50% of tumour cells, with no EGFR, ALK, or ROS1 aberrations, and who had received no prior systemic treatment for their advanced disease. Never smokers were ineligible for the study. The primary end points were OS and PFS, and the key secondary end point was ORR. Patient-reported outcomes included HRQoL. Overall, mean age was 63 years (standard deviation [SD]: 8.4), and 85% of patients were men. A non-squamous histology was observed in 56% of patients and the disease stage at screening was metastatic (stage IV) in 84% of patients. Patients had to have an ECOG PS of 0 or 1 and approximately 73% of the patients in both treatment arms had an ECOG PS of 1. All patients were current or former smokers as never smokers were excluded from the trial. Of 3,662 patients screened, 710 were randomized, 356 patients to the cemiplimab monotherapy arm and 354 patients to the chemotherapy arm. The mean duration of follow-up was 14.04 months (SD = 7.5) overall and in both treatment arms.
Due to issues with PD-L1 testing identified during the sponsor’s monitoring, samples from 235 patients tested before August 2018 had to be retested. Of these patients, 56 patients were found to have PD-L1 of less than 50% on retest. Consequently, a PD-L1 of at least a 50% population was pre-specified to include only patients with PD-L1 of at least 50% on retesting and those who were tested after August 2018 and were unaffected by testing irregularities. The PD-L1 of 50% or greater population consisted of 563 patients (n = 283 for cemiplimab and n = 280 for chemotherapy). Efficacy end points were assessed in the intention-to-treat (ITT) population (n = 710) as well as in the PD-L1 of 50% or greater population. Results for OS, ORR, PFS, and DOR in the PD-L1 of 50% or greater population were consistent with those in the ITT population.
As of the data cut-off date (March 1, 2020), the median OS was 22.1 months (95% confidence interval [CI] lower bound = 17.7 months) in the cemiplimab arm versus 14.3 months (95% CI, 11.7 to 19.2 months) in the chemotherapy arm (P = 0.0022); the hazard ratio (HR) between groups was 0.676 (95% CI, 0.52 to 0.87).
Mean baseline scores for the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) global health status (GHS) scale were similar between patients in the cemiplimab and chemotherapy treatment arms. Mean change in score from baseline of greater than 5 points for the GHS was observed in the cemiplimab arm by cycle 2 (mean change [SD] 5.16 [20.49]), above 9 points by cycle 6 (9.38 [23.359]) and above 10 points by cycle 18 (10.53 [25.71]). It stayed above 10 points, with wide variation thereafter, to cycle 30. Mean change for GHS score in the chemotherapy arm was below 3 until cycle 12 and ranged from −8.33 (24.40) at cycle 18 to 5.56 (12.73) at cycle 21. The mean GHS scores numerically favoured cemiplimab post-baseline up to cycle 6 and there were no consistent or notable differences between the arms at later time points.
Complete response or partial response was observed in 36.5% of patients in the cemiplimab arm and 20.6% of patients in the chemotherapy arm. The odds ratio for comparison of cemiplimab to chemotherapy was 2.21 (95% CI, 1.58 to 3.10; P < 0.0001).
The median PFS was 6.2 months (95% CI, 4.5 to 8.3 months) in the cemiplimab arm versus 5.6 months (95% CI, 4.5 to 6.1 months) in the chemotherapy arm (P < 0.0001); the HR between groups was 0.593 (95% CI, 0.491 to 0.718).
The Kaplan–Meier estimate of median DOR was 21.0 months (lower bound of 95% CI = 14.9 months) for cemiplimab and 6.0 months (95% CI, 4.3 to 6.4 months) for chemotherapy.
As of the data cut-off date, 88.2% of patients in the cemiplimab arm and 94.2% of patients in the chemotherapy arm had experienced at least 1 treatment-emergent adverse event (TEAE). In the cemiplimab arm, the most common TEAEs of any grade by preferred term experienced by at least 10% of patients were anemia (14.6%), decreased appetite (11.8%), and fatigue (10.1%). In the chemotherapy arm, the most common TEAEs of any grade by preferred term experienced by at least 10% of patients were anemia (50.0%), nausea (28.4%), alopecia (24.0%), decreased appetite (18.4%), neutropenia (18.4%), fatigue (17.0%), constipation (15.2%), thrombocytopenia (15.2%), vomiting (14.3%), neutrophil count decreased (12.3%), peripheral neuropathy (10.8%), pneumonia (10.8%), and platelet count decreased (10.5%).
Grade 3 to 4 TEAEs occurred in 28% of patients in the cemiplimab arm and 39% of patients in the chemotherapy arm. Discontinuation of study treatment due to AEs was reported for 6.5% of patients in the cemiplimab arm and 4.1% of patients in the chemotherapy arm. Serious TEAEs were reported for 28.2% of patients in the cemiplimab arm and 27.5% of patients in the chemotherapy arm.
TEAEs that led to death occurred in 9.6% of patients treated with cemiplimab and 9.1% of patients treated with chemotherapy. In 9 (3%) patients treated with cemiplimab, the events leading to death were considered related to treatment, and included autoimmune myocarditis, cardiac failure, cardiopulmonary failure, respiratory failure, septic shock, cardiorespiratory arrest, nephritis, and tumour hyperprogression (n = 1 each).
In the cemiplimab arm, 17.5% of patients experienced at least 1 treatment-emergent immune-related AE, and in the chemotherapy arm, 2.3% of patients experienced at least 1 treatment-emergent immune-related AE. Most of these events were less than grade 3, with 3.7% of patients in the cemiplimab arm and 0.3% of patients in the chemotherapy arm experiencing an immune-related AE that was grade 3 or higher. Grade 4 and 5 immune-related AEs were only reported in the cemiplimab arm, occurring in 0.8% and 0.3% of patients, respectively.
The EMPOWER-Lung 1 trial was an open-label trial, and although patient blinding would not have been possible given the differences in the 2 study treatment regimens, detection and performance bias that may result from lack of blinding of patients and investigators to assigned study treatments cannot be ruled out, especially for subjective patient-reported outcomes. Issues with PD-L1 testing were discovered when over 50% of the planned population had been recruited, necessitating retesting of the 235 randomized patients at that point, but not all of them had remaining tissue samples (38%) and not all of the retested samples proved to have PD-L1 of 50% or greater (24%). As a result, analyses were also conducted in the population with confirmed PD-L1 TPS of 50% or greater. The ITT population represents a truly randomized sample but includes some patients who did not in fact meet the inclusion criteria of the trial; the PD-L1 of 50% or greater population is not strictly a randomized sample and serves as supportive data, as it may be more clinically relevant. The findings across these 2 populations were largely similar. Amendments to the protocol were made to allow patients who progressed on cemiplimab monotherapy to continue cemiplimab treatment with the addition of 4 cycles of histology-specific chemotherapy until further progression was observed. Similarly, patients in the chemotherapy arm were allowed to cross over to cemiplimab after initial disease progression on chemotherapy. This crossover was not accounted for in the main OS analysis and may have biased the findings in favour of chemotherapy (i.e., underestimated the effect of cemiplimab). Sensitivity analyses were conducted to account for the crossover effect, and these were consistent with the primary analyses.
The EMPOWER-Lung 1 trial included a heterogenous population of patients with NSCLC and a wide range of clinical presentations were well-represented. However, a few patient groups were not included, notably never smokers and patients who were immunocompromised, or had a history of autoimmune diseases, and those with ECOG PS of 2 or higher. Therefore, generalizability of results to these patient groups may be limited. In addition, about 44% of patients presented with squamous histology, which is higher than what is expected in clinical practice (about 30%). The most important limitation of the evidence in terms of generalizability is the relevance of chemotherapy as a comparator in Canadian clinical practice, where the standard of care for the treatment of patients with advanced or metastatic high PD-L1 expressing NSCLC and without oncogenic alterations includes immune checkpoint inhibitors. Pembrolizumab, with or without chemotherapy, is funded and is widely used for this indication. Therefore, the benefit of cemiplimab compared to chemotherapy in terms of improved survival in this patient population is limited in informing treatment choice in Canadian clinical practice.
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Identified in the literature search were 2 additional published ITCs, 1 of which included a comparison of cemiplimab against pembrolizumab plus chemotherapy. However, due to serious limitations in the published ITCs, conclusions could not be drawn based on the findings and the results are not included in this summary.
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Few inferences can be made from the results of the network meta-analysis (NMA) because of important limitations with the included studies and the methods and assumptions made in the NMA. The key limitation related to the choice of relevant comparators did not include ||||||||||||||||||||||||||||||||||||||||||, a comparator considered to be relevant in the Canadian treatment landscape for patients with NSCLC expressing PD-L1 50% or greater, though the most relevant comparator, ||||||||||||||||||||||||, was captured. Therefore, the relevance of the systematic literature review and NMA to the Canadian context is unclear. The outcomes assessed were appropriate, though other important outcomes such as HRQoL were deemed not possible to analyze due to differences in study reporting. Moreover, several potential sources of heterogeneity exist across the trials that limit their comparison, including substantial heterogeneity across trial populations, such as tumour histology and smoking status. The available trials formed networks with no closed loops; therefore, it was not possible to validate the transitivity assumption of NMA and check for consistency of results between direct and indirect comparisons. Random-effects models were attempted and determined not to be feasible to include as the base-case analysis due to the small number of included studies.
Summary of Economic Evaluation.
The sponsor estimated the budget impact of cemiplimab over 3 years. CADTH identified the following key limitations with the sponsor’s analysis: treatment cost of pembrolizumab is overestimated, treatment duration adopted in the budget impact analysis is misaligned with the cost-utility analysis (CUA), and the number of patients eligible for cemiplimab is uncertain. CADTH reanalysis included applying weight-based dosing with vial sharing for pembrolizumab, aligning treatment duration estimates with the CUA, and revising the eligible population.
The sponsor’s results suggested that the reimbursement of cemiplimab would lead to a budgetary savings of $7,343,746 over a 3-year time horizon. In the CADTH base case, the budget impact of reimbursing cemiplimab is expected to be $2,341,491 in year 1, $5,563,150 in year 2, and $6,012,679 in year 3, with a 3-year total of $13,917,320. If a treatment stopping rule of 2 years is applied for cemiplimab to align with the R2810-ONC-1624 trial and funding criteria for pembrolizumab, the estimated budget impact decreases to $3,136,771.
Dr. Maureen Trudeau (Chair), Mr. Daryl Bell, Dr. Jennifer Bell, Dr. Matthew Cheung; Dr. Winson Cheung, Dr. Michael Crump, Dr. Leela John, Dr. Christian Kollmannsberger, Mr. Cameron Lane, Dr. Christopher Longo, Dr. Catherine Moltzan, Ms. Amy Peasgood, Dr. Anca Prica, Dr. Adam Raymakers, Dr. Patricia Tang, Dr. Marianne Taylor, and Dr. W. Dominika Wranik.
Meeting date: April 13, 2022
Regrets: Two members did not attend.
Conflicts of interest: None
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Indication: First-line treatment of adult patients with non–small cell lung cancer (NSCLC) expressing PD-L1 (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK, or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC
Sponsor: Sanofi Genzyme, a division of Sanofi-Aventis Canada Inc.
Final recommendation: Reimburse with conditions
Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
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