IN METASTATIC NSCLC WITH CERTAIN ACTIONABLE MUTATIONS
IMMUNOTHERAPY IS NOT AN APPROPRIATE FIRST-LINE CHOICE*
SEQUENTIALLY SAFE
EFFECTIVE
TARGETED THERAPY
INDICATED
*Not applicable to patients with a KRAS G12C or ERBB2 (HER2) mutation without another actionable mutation or patients with certain EGFR exon 20 insertion mutations.14-17
†Based on 6 studies of 3867 patients with NSCLC and EGFR sensitizing mutations, and 1 study including 345 patients with NSCLC and ALK mutations. Of the 3867 patients with EGFR mutations, 395 were treated with immunotherapy followed by EGFR TKIs. Of the 345 patients with ALK mutations, 3 were treated with immunotherapy followed by an ALK TKI. Adverse reactions, including ILD and hepatotoxicity, were observed following the sequential use of IO followed by TKI therapy in patients who had actionable mutations.1-7
‡Phase 2, single-arm study of pembrolizumab in patients with advanced EGFRm NSCLC. 82% of enrolled patients were treatment naïve. The clinical study was stopped due to lack of efficacy after 11 of 25 planned patients were enrolled. No responses were observed in 10 of the 11 patients treated, even in patients with PD-L1 expression ≥50%. The patient who did have a response was revealed to be EGFR wild-type upon repeat analysis.13
National Comprehensive Cancer Network® (NCCN®) RECOMMENDATION
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend that patients with mNSCLC should be tested for certain driver mutations, including EGFR, ALK, KRAS, ROS1, BRAF, NTRK 1/2/3, MET exon 14 skipping, RET, and ERBB2 (HER2).18*§
NCCN
RECOMMENDATION
For patients who require an urgent start to therapy but molecular testing is pending, consider holding immunotherapy for one cycle unless confirmed that no driver mutations are present.18
- ASCO Recommendation 1.8: In the first-line setting, for patients with mNSCLC with any activating EGFR mutation (including exon 20 insertion mutations), regardless of PD-L1 expression levels, single-agent immunotherapy should not be used19
- Fourteen large and robust first-line IO trials excluded patients with NSCLC who had EGFR or ALK mutations20-33||
CONFIRM THERE ARE NO ACTIONABLE MUTATIONS
BEFORE TREATING YOUR PATIENT WITH mNSCLC WITH 1L IMMUNOTHERAPY
§The NCCN Guidelines® for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques, but do not endorse any specific commercially available biomarker assays or commercial laboratories.18
||KEYNOTE-024, KEYNOTE-042, KEYNOTE-021 Cohort G, KEYNOTE-189, CHECKMATE 026, CHECKMATE 227, CHECKMATE 9LA, IMpower110, IMpower130, IMpower132, IMpower150, POSEIDON, EMPOWER-Lung 1, and EMPOWER-Lung 3 did not allow patients with treatment-naïve metastatic EGFR or ALK mutation-positive NSCLC. In the IMpower130 and IMpower150 trials, patients with metastatic EGFR or ALK mutation-positive NSCLC were allowed only after progression on TKI therapy or intolerance to TKI treatment. There are no head-to-head trials comparing IO and EGFR or ALK-TKIs in patients with EGFR or ALK mutation-positive NSCLC.20-33
>1 MORE YEAR
of median OS
with targeted therapy vs no targeted therapy
Median overall survival (95% CI): Actionable mutation + targeted therapy, 3.49 years (3.02, 4.33); actionable mutation + no targeted therapy, 2.38 years (1.81, 2.93); no actionable mutation, 2.08 years (1.84, 2.46)
CONFIRMING DRIVER MUTATIONS AND TREATING WITH GUIDELINE-RECOMMENDED THERAPY
MAY LEAD TO A LONGER LIFE
IN A RETROSPECTIVE STUDY MORE THAN HALF OF ELIGIBLE PATIENTS WITH EGFRm OR ALK+ mNSCLC DID NOT RECEIVE FIRST-LINE TARGETED TREATMENT BECAUSE TESTING RESULTS WERE PENDING35†
57%
43%
DID NOT
RECEIVE AN EGFR TKI
RECEIVED AN EGFR TKI
EGFRm
58%
42%
DID NOT
RECEIVE AN ALK INHIBITOR
RECEIVED AN ALK INHIBITOR
ALK+
*Multicenter US study of 1017 patients with metastatic lung adenocarcinoma to determine the frequency of 10 oncogenic drivers, including MET, ALK, and EGFR alterations.34
†Retrospective analysis of data from 206 community cancer sites to assess the adherence to guidelines for EGFR and ALK testing for mNSCLC and the timing associated with receipt of test results. Data were analyzed for 16,316 patients with mNSCLC diagnosed after January 1, 2014, with at least 2 visits before December 31, 2016.35
HELP DETERMINE YOUR PATIENTS’ BIOMARKER STATUS
AT THE EARLIEST OPPORTUNITY TO HELP INFORM GUIDELINE-RECOMMENDED TREATMENT OPTIONS
IN mNSCLC
APPROPRIATE 1L TREATMENT STARTS WITH KNOWING THE DRIVER OF DISEASE
MORE THAN 50%
of your patients with mNSCLC of
adenocarcinoma histology may have an actionable mutation*
Mutations in patients with mNSCLC of adenocarcinoma histology36-38*
KNOWING PD-L1 STATUS IS NOT ENOUGH TO MAKE A 1L TREATMENT DECISION
Overlap of EGFR mutations and PD-L1 expression39-43§
PD-L1
EGFRm
EGFRm
& PD-L1
UP TO 70%
of patients with EGFRm mNSCLC also express PD-L1 at levels >1%39-43
Overlap of additional driver mutations and PD-L1 expression40||
| Driver mutation | % with PD-L1 expression (PD-L1 expression >1%/PD-L1 status available) |
|---|---|
| ROS1 | 100.0 (5/5) |
| MET | 75.0 (15/20) |
| RET | 75.0 (6/8) |
| BRAF | 70.0 (7/10) |
| KRAS | 66.3 (63/95) |
| ALK | 63.6 (7/11) |
| HER2 | 53.3 (8/15) |
- EGFR is a common driver of disease in patients with mNSCLC who also express PD-L1
National Comprehensive Cancer Network® (NCCN®) RECOMMENDATION
TARGETED THERAPY TAKES PRECEDENCE: Treatment with targeted therapy should take precedence over treatment with immunotherapy in patients with mNSCLC and certain oncogenic drivers in the first-line setting, even when PD-L1 expression levels are elevated.18
- NCCN Guidelines recommend that clinicopathologic features such as ethnicity, smoking status, or histology should NOT be used to select patients with mNSCLC for EGFR mutational testing18
In metastatic NSCLC, don’t assume your patients’ biomarker status
TEST EVERY ELIGIBLE PATIENT FOR ACTIONABLE MUTATIONS, REGARDLESS OF PHENOTYPE
Clinicopathologic features in patients with metastatic EGFRm NSCLC treated with EGFR TKIs (N=1151)44¶
46% History of smoking (n=534)
32% Male (n=366)
85% Non-Asian (n=842)#
*Jordan et al (2017) prospectively analyzed a total of 915 tumors from 860 patients with recurrent or metastatic lung adenocarcinoma for mutations in >300 cancer-associated genes using the Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT) assay, a hybridization capture-based, next-generation sequencing platform.36
†Gatalica et al (2019) reviewed a large cohort of solid malignancies profiled by a commercial laboratory that were tested for NTRK gene fusions and other pathogenic/targetable genomic and protein alterations. Patients’ stage of disease was not disclosed. 4073 patients in the study had non-small cell lung carcinomas of adenocarcinoma histology, of which 4 patients had an NTRK fusion.37
‡Nassar et al (2021) extracted data from the registry of the American Association for Cancer Research Project Genomics Evidence Neoplasia Information Exchange (GENIE) version 8.0 to study the distribution of KRAS mutations in 32,138 patients with cancer across race and sex. KRAS mutations were identified in 1867 samples, most frequently in patients with NSCLC (1443 of 10,444). 76.3% of patients with NSCLC had lung adenocarcinoma histology. Patients’ stage of disease was not disclosed.38,45
§Mazieres et al (2019) was a multicenter, international, retrospective study of 551 patients receiving ICI monotherapy for advanced NSCLC with at least one oncogenic driver alteration. 125 patients had an EGFR mutation. D'Incecco et al (2015) was a multicenter, retrospective, Italian study that assessed PD-L1 expression in 125 patients with mNSCLC and EGFR mutations, ALK translocations, or KRAS mutations. 56 patients had an EGFR mutation. Dietel et al (2019) was a multicenter, international, retrospective study that examined PD-L1 expression in 2368 tumor samples with histologically confirmed stage IIIB/IV primary NSCLC as classified by AJCC 7th edition. 448 patients had an EGFR mutation. Brown et al (2020) analyzed PD-L1 expression in 231 samples of untreated, EGFR-mutated, advanced NSCLC.39,41-43
||From a multicenter, international, retrospective study of 551 patients receiving ICI monotherapy for advanced NSCLC with at least one oncogenic driver alteration (EGFR [exon 18-21] activating mutation, HER2 [exon 20] activating mutation, KRAS mutation, BRAF [exon 15] mutation, MET amplification or exon 14 mutation, ALK rearrangement, ROS1 rearrangement, or RET rearrangement). A total of 34 patients with more than one driver were allocated to the dominant oncogenic driver. Optionally, investigators were asked to record PD-L1 expression in tumor cells. The purpose of the study was to analyze the clinical activity of ICI therapy in the context of oncogenic driver alterations.40
¶EGFR TKI prescription data from Flatiron Health EHR-derived database. Included 1151 patients who started treatment between October 1, 2017, and April 30, 2020.44
#Calculations are based on those who specified race and exclude the 157 patients in the study for whom race was not specified.44
ONE MISSED PATIENT IS TOO MANY
TEST EVERY ELIGIBLE PATIENT FOR ACTIONABLE MUTATIONS AND TREAT WITH GUIDELINE-RECOMMENDED TARGETED THERAPY WHEN APPROPRIATE
LIQUID BIOPSY PLUS TISSUE TESTING IS CRITICAL TO HELP FIND MORE ACTIONABLE MUTATIONS
- In a clinical study, liquid biopsy plus tissue testing together increased the detection of actionable mutations by 17% over tissue testing alone46*
INTEGRATE LIQUID BIOPSY TO BE SURE OF A PATIENT’S STATUS
ADVANTAGES OF LIQUID BIOPSY
- Reduces turnaround time for results
Roughly half the time vs tissue (9 vs 15 days)47† - An available option when retrieving tissue is not feasible
~23% were found to have actionable mutations with liquid biopsy46*‡ - Addresses cases of tissue QNS
~28% were found to have actionable mutations with liquid biopsy46*§
- Non-invasive procedure process48
- Simple blood test
Ease of monitoring patients48|| - Procedure setting
Home or office (hospitalization not required)49,50
Positive liquid biopsy results are sufficient to inform treatment selection51
Negative liquid biopsy results should be reflexed to tissue biopsy51
IN A CLINICAL STUDY, CONCURRENT LIQUID BIOPSY AND TISSUE TESTING INCREASED THE DETECTION OF ACTIONABLE MUTATIONS FROM 20.5% TO 35.8%46*
*From a single-center, prospective cohort study of 323 patients with histologically confirmed stage IV NSCLC who had plasma testing as part of routine clinical management.46
†Multicenter North American study of 282 patients with stage IIIB or stage IV NSCLC using next-generation sequencing as the testing platform. ~98% of patients had stage IV disease. Turnaround time is for next-generation sequencing.47
‡5 out of 22 (23%) patients whose tissue was not able to be retrieved for biopsy were found to have actionable mutations through liquid biopsy only.46
§22 out of the 79 (28%) patients who did not have a sufficient quality/quantity of DNA were found to have targetable mutations via liquid biopsy.46
||Based on Wu et al (2019), a review of the current clinical applications and future directions of liquid biopsy in the management of NSCLC.48
COMBINE TISSUE AND LIQUID BIOPSY TO HELP CONFIRM MUTATION STATUS AND INFORM APPROPRIATE TREATMENT
1L, first-line; AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; ASCO, American Society of Clinical Oncology; BRAF, v-raf murine sarcoma viral oncogene homolog B1; CI, confidence interval; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; EHR, electronic health records; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; G12C, glycine-to-cysteine substitution at codon 12; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; IASLC, International Association for the Study of Lung Cancer; ICI, immune checkpoint inhibitor; ILD, interstitial lung disease; IO, immunotherapy; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MET, mesenchymal-epithelial transition; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; QNS, quantity not sufficient; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor.
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