LONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Erlotinib for the third or fourth-line treatment of NSCLC January 2012

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1 Disease background LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Erlotinib for the third or fourth-line treatment of NSCLC January 2012 Lung cancer is the second most common cancer in the UK (after breast), accounting for 1 in every 8 new cancer diagnoses, and is the most common cause of death from cancer in both men and women (responsible for 24% of all male cancer deaths and 21% of all female cancer deaths). In 2008, a total of 40,806 people in the UK were diagnosed with lung cancer (ageadjusted incidence rate of approximately 48 per 100,000 population) and 35,261 deaths were registered (40 per 100,000 population) (1). Non-small lung cancer (NSCLC) is the most common histological type of lung cancer (85-90%) and consists of three main types: squamous cell carcinoma (45%), adenocarcinoma (45%) and large cell carcinoma (10%). About 30% of NSCLC cases present with locally and regionally advanced disease (Stage IIIb) and 40% with advanced disease (Stage IV, in which there are distant metastases or a pleural or pericardial effusion). Prognosis for these patients is poor (1-year survival rate of 28%) and the aims of treatment are to prolong survival and improve quality of life (2). The NICE clinical guideline on lung cancer (CG121) recommends that chemotherapy be offered to patients with stage III or IV NSCLC who have a good performance status (WHO 0, 1 or Karnofsky score of ) to improve survival, disease control and quality of life (3). When estimating the cost impact of its 2005 guidance on the treatment of lung cancer, NICE used an upper estimate of 30% as the proportion of patients with NSCLC who may potentially receive first-line chemotherapy (no information is included in the 2011 updated guideline costing template). It is then estimated that around one third to one half of those receiving first-line therapy will be suitable for second-line treatment; no estimates of the proportion of patients receiving treatment beyond this are given (4). National guidance Epidermal Growth Factor Receptors (EGFRs) are over-expressed in various solid tumours, including NSCLC, and have an important role in major signalling cellular pathways involved in tumour genesis and tumour growth (11). Erlotinib (Tarceva ) is an orally administered tyrosine kinase inhibitor that specifically targets the tyrosine kinase domain of the EGFR receptor. It is licensed in the UK for the treatment of locally advanced or metastatic NSCLC both in the first-line setting (in patients with EGFR activating mutations) and in patients who have received prior chemotherapy; it is additionally indicated for maintenance treatment in patients with stable disease following four cycles of standard platinum-based chemotherapy (5). NICE has issued the following guidance relevant to patients with NSCLC who have been previously treated: Erlotinib (TA 162): NICE has recommended erlotinib as an alternative to docetaxel as a second-line treatment option for patients with locally advanced or metastatic NSCLC if it is provided by the manufacturer at an overall treatment cost equal to that of docetaxel. It is not recommended for use in this setting in patients for whom docetaxel is unsuitable or for third-line treatment after docetaxel therapy (i.e. for those in whom best supportive care [BSC] would be the alternative) (6). The updated NICE clinical guideline on lung cancer states that docetaxel monotherapy should be considered if second-line treatment is appropriate for patients with locally

2 advanced or metastatic NSCLC in whom relapse has occurred after previous chemotherapy (3). Pemetrexed (TA 124): Pemetrexed is licensed for use as monotherapy in the treatment of locally advanced or metastatic NSCLC (other than predominantly squamous cell histology) after prior chemotherapy (7). NICE does not recommend the use of pemetrexed for this indication, as it does not represent a cost-effective use of NHS resources when compared with either docetaxel or BSC (8). No therapies are recommended by NICE for use in the third or fourth-line settings. Erlotinib is not recommended as a third-line treatment, where the alternative is BSC; fourth-line treatment was not evaluated (the BR 21 study only included one patient treated in this setting, which was against protocol) (9). Guidelines from the National Comprehensive Cancer Network (NCCN) note that responses to second-line chemotherapy in advanced NSCLC have generally been less than 10%, despite the availability of a number of new therapies. They recommend docetaxel, pemetrexed, erlotinib or a platinum doublet as second-line therapy for patients with a PS of 0-2 who have experienced disease progression during or after first-line therapy. In addition, erlotinib is recommended for second- or third-line therapy for progressive disease in patients with a PS of 3 or 4 who have an EGFR mutation. If disease progression occurs after third-line chemotherapy, patients with a PS of 0-2 may be treated with BSC or enrolled in a clinical trial (10). Summary of current treatment options/comparators There does not appear to be an established third-line (or beyond) treatment option for patients with advanced NSCLC; most patients in practice will receive BSC (4). The NCCN guidelines suggest erlotinib as an option for third-line therapy in patients with PS of 3 or 4 who have an EGFR mutation; beyond this BSC is the only option, or enrolment into a clinical trial. NICE does not recommend erlotinib for third-line therapy, where BSC would be the alternative option (6). BSC would therefore be considered the most appropriate comparator for the indication under review. Evidence for erlotinib in the third- or fourth-line treatment of NSCLC The licensing of erlotinib for the treatment of patients with locally advanced or metastatic NSCLC who have received prior chemotherapy was based on the results of the BR21 study (13). BR21 was an international, multicentre, placebo-controlled Phase III study designed to evaluate the safety and efficacy of erlotinib plus BSC versus BSC alone in the treatment of patients with stage IIIB or IV NSCLC. A total of 731 adults who had received either one or two previous lines of treatment (and were considered ineligible for further chemotherapy), and who had an ECOG performance status of 0-3, were randomised to receive erlotinib (150mg daily; n=488) or placebo (n=243). Randomisation was stratified according to treatment centre, performance status, response to previous chemotherapy, number of prior regimens (one versus two), and exposure to prior platinum therapy. There was no pre-selection of patients based on EGFR expression (14). Information on EGFR expression at baseline was available for 31% of the patients in the erlotinib arm and for 35% in the placebo arm. In the erlotinib arm, 16% of patients (representing 51% of the patients with known results) had a positive EGFR expression and 15% (49% of the patients with known results) had a negative expression, compared with 20% and 15% (representing 57% and 43% of patients with known results) in the placebo arm (12). The SPC for erlotinib notes that no 2

3 survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with EGFR-negative tumours (5). The median age of the participants was 61 years and around 65% were male. The majority of patients were current or ex-smokers (73% erlotinib; 77% placebo) and over half (52.5% erlotinib; 54.3% placebo) had an ECOG PS of 1. A total of 51% had received one previous chemotherapy regimen and 49% had received two; most (92%) had received prior platinumbased therapy (4). [Of note the main trial publication states that 49% of patients had received two or more previous regimens; a presentation of the study prepared for and presented at ASCO 2004 states that only 1% of patients had received three previous regimens, and the receipt of more than two prior chemotherapy regimens was an exclusion criteria] (4, 9). The Evidence Review Group (ERG) who reviewed the BR21 study for the NICE technology appraisal on erlotinib raised concern that the low median age (that is, a median age likely to be younger than those presenting with NSCLC in the UK) may reflect the exclusion criteria applied (e.g. cardiac disease; any other underlying disease) and comment that the trial population is likely to be unrepresentative of the general population of NSCLC patients. Despite this possibly healthier patient population, the Group noted that it included a large number of patients with ECOG PS 2-3; such patients do not often receive chemotherapy unless as part of a clinical trial. The Appraisal Committee commented that the study included a higher proportion of non-smokers than would be expected in clinical practice (4, 6). The primary endpoint was overall survival (OS); secondary endpoints included progressionfree survival (PFS), overall response rate, duration of response, toxicity and quality of life (QoL). Of note, central radiology review was not performed for the majority of patients in the trial, and blinding of local investigators may have been compromised by the identification of erlotinib therapy in patients presenting with rash (4). The main findings were as follows (4): Median OS was 6.7 months (95% CI months) in the erlotinib group and 4.7 months (95% CI months) in the placebo group. This is equal to an absolute increase in median OS of 2.0 months with erlotinib (adjusted HR 0.70; 95% CI ; p<0.001) (4) For those who were being treated third-line, median OS was 6.8 months in the erlotinib group and 4.6 months in the placebo group for a difference of 2.2 months (HR of 0.75; 95% CI ; p=0.02). Subgroup analyses according to EGFR status (for those known; n=141) showed no benefit for those with EGFR-negative tumours (OS HR 0.93; ). There was a survival benefit for erlotinib seen in those with EGFR-positive tumours (0.68; 95% ) (12) The 1-year survival rate was 31% in the erlotinib group and 22% in the placebo group Median PFS was 2.2 months in the erlotinib group and 1.8 months in the placebo group (adjusted HR 0.61; 95% CI ; p<0.001) The overall response rate was 8.9% ( %) in the erlotinib group and 0.9% ( %) in the placebo group. The median durations of response were 7.9 months and 3.7 months, respectively Exploratory analyses were performed to adjust for treatment effect and to identify prognostic factors for PFS and OS. Response to erlotinib was found to be higher among Asians (p=0.02), women (p=0.006), adenocarcinoma patients (p<0.001), non-smokers (p<0.001) and patients in whom 10% or more of the tumour cells expressed EGFR (p=0.10). These subgroup analyses were not however powered to detect statistically significant benefits. Further analysis showed 3

4 that Asian origin, adenocarcinoma and a history of not smoking were predictors of survival; only the interaction between smoking and treatment was however significantly predictive of a differential effect on survival (15). The primary endpoints for the QoL analyses were defined as the time to deterioration (change from baseline of 10 points or more on a 100-point scale) of cough, dyspnoea and pain. Deterioration of cough was reported in 32% vs. 41% of patients, deterioration of dyspnoea by 40% vs. 44%, worsening fatigue by 51% vs. 55% and worsening pain by 43% vs. 51% of patients in the erlotinib and placebo arms, respectively. Patients in the erlotinib arm had clinically significantly longer time to deterioration for these three tumour-related symptoms: 4.9 vs. 3.7 months for cough (p=0.04), 4.7 vs. 2.9 months for dyspnoea (p=0.03), and 2.8 vs. 1.9 months for pain (p=0.04). In addition to QoL benefits observed for these tumour-related symptoms, differences were also seen in the physical function domain (31% improved on erlotinib vs. 19% on placebo, p=0.01) and in global QoL (35% vs. 26%, p<0.01) (14). Patients treated with erlotinib did however have inferior QoL responses in terms of diarrhoea and sore mouth (4). EGFR mutations in the region encoding the tyrosine kinase domain (exons 18-21) have been identified in patients with NSCLC, with evidence to suggest that they can be used to predict responsiveness to erlotinib. The results of assays for the number of copies and mutation status of the EGFR gene in a subgroup of patients in the BR 21 study were published separately (16) and are noted in the EPAR (12). EGFR mutation status was only known for 117 patients (16%); among these, EGFR mutational status was not statistically significantly associated with response (7% wild-type and 16% of those with an EGFR mutation; p=0.37) or survival (16). The authors later reported an updated analysis, taking into account further samples that became available after the original publication, and the results of a reanalysis of EGFR mutation status, using more sensitive assays (17). Of the 204 tumours analysed, 34 (17%) had EGFR exon 19 deletion or exon 21 L858R mutations; responses were higher in these patients than in those with wild-type EGFR (27% versus 7%, respectively; p=0.03). No statistically significant survival benefit was however seen in patients with mutant EGFR (HR 0.55; p=0.12). Although the SPC states that EGFR mutation testing should be performed prior to initiation of erlotinib therapy in chemotherapy-naïve patients with advanced or metastatic NSCLC (as per the main registration study for this indication), this is not required for patients who have already received previous treatment (5). Main toxicities The most commonly reported toxic effects associated with erlotinib in BR21 were nonhaematological, including rash (76%) and diarrhoea (55%); these were generally mild to moderate in nature, with 9% of patients suffering grade 3/4 rash and 6% of patients suffering grade 3/4 diarrhoea (0% and <1% in the placebo arm, respectively). Whilst all grades of infection were reported more frequently in the erlotinib arm (34% versus 21%, P=<0.001) grade 3 to 4 infection was reported more frequently in the placebo arm (2% versus 5%, P=0.03) (4). In the erlotinib group, 19% of patients required a dose reduction because of drug-related toxic effects (mainly rash or diarrhoea) compared to 2% of patients in the placebo group. A total of 5% of patients discontinued erlotinib due to drug-related toxic effects compared to 2% in the placebo arm (4). 4

5 NICE appraisal of BR21 data for TA 162 The manufacturer s submission initially focused on a comparison of erlotinib with docetaxel (using indirect data), then at the request of the Committee they carried out two further costeffectiveness analyses a comparison of erlotinib to BSC in second-line therapy (for patients for whom docetaxel is unsuitable) or third-line therapy (following treatment with docetaxel). This was based on data from the BR21 study. The manufacturer s analysis concluded that the incremental cost-effectiveness ratios (ICERs) for the comparisons of erlotinib with BSC were 78,300 per QALY gained for the second-line group and 54,200 per QALY gained for the third-line group. The Committee therefore concluded that erlotinib was not a cost-effective use of NHS resources for the treatment of patients with locally advanced or metastatic NSCLC for whom docetaxel is unsuitable as second-line treatment or following docetaxel as second-line treatment (i.e. as third-line treatment), for patients who would normally receive BSC. The Committee considered the current evidence base to be insufficient to allow conclusions to be reached about the targeting of specific subgroups (including EGFR status) for erlotinib treatment. Cost estimations Population estimates N per 100,000 population Incidence of lung cancer in the UK 48 85% have NSCLC 41 70% present with stage IIIb or IV disease 29 Assuming all are eligible for first-line therapy 29 50% go on to receive second-line therapy 15 50% eligible for third-line therapy (and possible for treatment with erlotinib)* Drug cost estimates 5 7 Cost Cost per 30 days of erlotinib 150mg (net price) 1,632 Cost per treatment (based on the 2.2 months of treatment)** 3,640 Cost per 100,000 population 25,480 *This is assuming no targeting of treatment to those subgroups found to be more likely to benefit ** Length of treatment was not stated in the clinical trial, therefore the median PFS in the erlotinib group has been used as an estimate Summary/points of consideration There does not appear to be an established third-line (or beyond) treatment option for patients with advanced NSCLC; most patients in practice will receive BSC. The Phase III BR.21 study showed that erlotinib was associated with an overall absolute increase in survival of 2.0 months compared to BSC, in the treatment of patients with advanced NSCLC who had received one or two previous lines of therapy. For those being treated third-line (49%), the difference was 2.2 months (median of 6.8 months in the erlotinib group and 4.6 months in the placebo group; HR of 0.75; 95% CI ; p=0.02). Although not powered to detect statistically significant differences in subgroups, exploratory analyses suggested that a number of characteristics may be associated with improved response to erlotinib, including female sex, adenocarcinoma and never having smoked (only the latter was

6 found to be a significant predictor of survival). Further analyses showed that EGFR mutations were associated with an increased response rate; the difference in overall survival did not however meet statistical significance (HR 0.55; p=0.12). Only 1% of the study population were treated after receiving three previous lines of therapy (i.e. as fourth-line) and it therefore does not provide any evidence of the use of erlotinib in this setting. This study was conducted prior to the introduction of new agents for the treatment of NSCLC, and it is unclear how the results would apply to patients who have received previous treatment with such agents, for example gefitinib. Also would patients who have been previously treated with erlotinib second-line, according to NICE guidance, be eligible for rechallenge in the thirdline setting? NICE has recommended the use of erlotinib only in the second-line treatment of NSCLC in patients who would otherwise be eligible for docetaxel treatment, and where the costs of providing the treatments are equal (provided on a discounted basis by Roche). It does not consider erlotinib to be a cost-effective use of NHS resources if used as third-line treatment ( 54,200 per QALY gained), and compared to BSC. As the standard third-line treatment in practice would be BSC, there are no data available on the number of people reaching this stage who would possibly be eligible for treatment with erlotinib. Based on an estimation of 7 eligible patients per 100,000 population, use of erlotinib as a third-line therapy would be associated with a drug cost of approximately 25,500 per 100,000 population. List of references reviewed: 1) Cancer Research UK: Statistics on lung cancer. Accessed via on 5/1/2012 2) NICE: Lung cancer (non small cell, EGFR-TK mutation positive) - erlotinib (1st line): final scope 3) NICE Clinical Guideline: The diagnosis and treatment of lung cancer (published April 2011) 4) NICE ERG report: Erlotinib for the treatment of relapsed non-small cell lung cancer. Accessed via 5) Erlotinib (Tarceva ) SPC (last reviewed 24/8/2011); accessed via 6) NICE TA 162: Erlotinib for the treatment of non-small-cell lung cancer (November 2008) 7) Pemetrexed (Alimta ) SPC (last reviewed 24/10/2011); accessed via 8) NICE TA 124: Pemetrexed for the treatment of non-small-cell lung cancer (August 2007) 9) Shepherd FA et al (2004) A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1st line or 2nd line chemotherapy. A National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trial. Presentation at 2004 ASCO Annual Meeting; abstract 7022 (copy of presentation provided with the application form) 10) National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Non-small cell lung cancer (version 2, 2012) 11) CHMP variation assessment report for Tarceva (July 2011) _Variation/human/000618/WC pdf 12) European Medicines Agency: Tarceva scientific discussion _Scientific_Discussion/human/000618/WC pdf 13) Shepherd FA et al (2005) Erlotinib in previously treated non-small cell lung cancer. NEJM; 353(2): ) SMC advice on erlotinib, 25, 100 and 150mg film-coated tablets (Tarceva ); issued November Tarceva FINAL_Nov_05 Amended_ for_website.pdf 6

7 15) Regional Drug and Therapeutics Centre (Newcastle): The use of erlotinib in the management of non small cell lung cancer (2006) 16) Tsao M-S et al (2005) Erlotinib in lung cancer molecular and clinical predictors of outcome. NEJM; 353: ) Zhu C-Q et al (2008) Role of KRAS and EGFR as biomarkers of response to erlotinib in national Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol; 26(26): ) NICE Technology Appraisal Guidance: Gefitinib for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer (TA192; published July 2010) 19) NICE Technology Appraisal Guidance: Pemetrexed for the first-line treatment of non-small-cell lung cancer (TA181; published Sep 2009) 20) Gefitinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) NICE Evidence Review Group report 21) Rosell R et al (2009) Screening for Epidermal Growth Factor Receptor Mutations in Lung Cancer. N Engl J Med; 361:

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