Advancing Personalized Therapy for Advanced Non-Small Cell Lung Cancer

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1 GUIDING THE WAY White Paper Advancing Personalized Therapy for Advanced Non-Small Cell Lung Cancer is a serum proteomic test for patients with advanced non-small cell lung cancer that helps healthcare providers determine therapy when considering or single-agent chemotherapy based on NCCN recommendations. 1 and Oncology Nurses Despite recent declines in death rates, non-small cell lung cancer (NSCLC) remains a serious public health problem in the United States. 2 Siegel et al. estimate that in 2012, there will be 226,160 new diagnoses of lung cancer and 87,750 deaths. 2 Lung and bronchus cancers are the second most common cancers among both men and women and the largest cause of cancer death. 2 Five-year survival rates for patients diagnosed with localized lung cancer remain around 50%, while five-year survival rates for patients diagnosed with regional or distant metastases (advanced) are less than 25% and approximately 4% respectively. 2 At the same time, well over half of all lung cancer diagnoses are made with distant metastases. 2 An extrapolation of the estimates suggests that in 2012, more than 113,000 people will be diagnosed with advanced lung cancer, and the likelihood of their survival beyond a few months is low. Advances in Understanding and Treating NSCLC Over the last decade or more, dramatic advances have been made in understanding NSCLC and its treatment. Those advances began with improvements over the first categorizations of lung cancers: small cell vs. non-small cell and then adenocarcinoma vs. squamous cell histology. Researchers have long recognized that lung cancers are about 10%-15% small cell and 85%-90% non-small cell. 3 In 2000, scientists believed that that NSCLC itself was comprised primarily of two histological types: adenocarcinoma (65%) and squamous cell (35%). In 2012, the picture is far more complex. There are at least four histological categories within NSCLC: Large cell (10%-15% of cases) Squamous cell (25-30% of cases) 1

2 No mutation: 46% EML4-ALK: 7% Adenocarcinoma (40% of cases) Other forms (15%-25% of cases) 3 Scientists have also learned that there are significant differences among patients as NSCLC demonstrates genetic variations. In 1987, the only genetic classification available was Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation. In 2004, epidermal growth factor receptor (EGFR) mutations were identified. 4 Figure 1 shows the current thinking about the distribution of significant genetic mutations or fusions in NSCLC. More than half of the cases are believed to have mutations in KRAS, epidermal growth factor receptor (EGFR), or other genes or combinations of genes. 5 Many physicians use biomarkers to help select the most appropriate therapy for each patient. This is known as personalized therapy. Table 1 shows an overall view of available biomarker tests and how they help in selecting therapy. EGFR Mutations and EML4-ALK Rearrangement The two most-commonly used genetic tests look at EGFR mutations and EML4-ALK rearrangements in patients with EGFR: 17% Kras: 22% The smaller pieces, from left to right: AKT1, NRAS, MEK1, HMET AMP, HER, PIK3CA, BRAF: 2%, Double mutants: 3% Figure 1. Proportion of Mutations in Cases of NSCLC (Adenocarcinoma) Kris MG, Johnson BE, Kwiatkowski DJ, et al. Identification of driver mutations in tumor specimens from 1,000 patients with lung adenocarcinoma: The NCI s Lung Cancer Mutation Consortium (LCMC). J Clin Oncol. 29: 2011 (suppl; abstr CRA7506). * The figure applies only to NSCLC identified as adenocarcinoma. No biomarkers have been identified for non-adenocarcinoma. 2 NSCLC. Research has demonstrated that patients with NSCLC who harbor EGFR mutations respond differently to certain treatment options than do patients without the mutation (or EGFR wildtype). For example, Mok et al. studied Asian patients with advanced NSCLC (never or light ex-smokers, adenocarcinoma), who were treated with either gefitinib, an EGFR tyrosine kinase inhibitor, or a carboplatin/paclitaxel regimen. Treatment outcomes appeared to be the same in both arms until investigators analyzed subsets of patients with EGFR mutations and those without the mutation (EGFR wild-type.) They found that patients whose cancers were EGFR mutation positive had better progression free survival (PFS) on gefitinib than on chemotherapy, and patients whose cancers were EGFR wild-type had better PFS on chemotherapy than on gefitinib in a first-line treatment setting. 6 Another study examined only patients with EGFR mutations (advanced NSCLC, treatment naïve, good performance status), again comparing a gefitinib regimen to one combining carboplatin and paclitaxel. 7,8 PFS (the primary endpoint) was better in patients treated with gefitinib, and those patients also showed a longer overall survival (OS). Recently, the potential importance of an EML4-ALK rearrangement has also been demonstrated for a small group of patients with NSCLC. A fusion gene, echinoderm microtubule associated protein like 4 anaplastic lymphoma kinase (EML4-ALK, commonly called EML4/ALK fusion), with transforming activity has been identified in a subset of NSCLC. 9 It can be detected using fluorescence in situ hybridization (FISH). 10 Shaw et al. have shown that in a group of 141 patients with NSCLC, 13% were positive for EML4/ALK fusions. Most were male, young, non-smokers, and there was no overlap with EGFR and KRAS mutations. They tended to be refractory to EGFR TKIs, and they had typical chemotherapy responses, not an increased response as seen with EGFR mutations. 11 In 2011, a new agent, crizotinib (Xalkori,Pfizer) received FDA approval to treat patients who test positive for EML4/ALK fusions on the basis of a trial that showed marked activity for the agent in such patients. 11,12 Crizotinib is an ALK and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor.

3 Table 1. Biomarker Information Available for Patients with NSCLC* Test Turnaround Result Associated Therapy Tissue genetics: performed at diagnosis prior to initiation of first-line treatment EGFR mutation 1 21 days Mutated Suggests sensitivity to (Tarceva, Genentech) Wild-type Other KRAS 21 days Mutated Suggests resistance mutation 1 to Wild-type Other EML4-ALK gene rearrangement days Positive Negative Suggests sensitivity to crizotinib (Xalkori, Pfizer) Other ERCC1 21 days Low expression Suggests response expression 1 to platinums High expression Other RRM1 expression 1 21 days Low expression Suggests response to gemcitabine (Gemzar, Eli Lilly) High expression Other Serum-proteomic test: performed prior to initiation of first-, second- and third-line treatment when selecting therapy between or single-agent chemotherapy 2, <72 hours Good Suggests response to 3 Poor Other *Information provided does not suggest clinical usage and a qualified physician should use clinical judgment when applying biomarker information. test results should be used in combination with the patient s clinical history, other diagnostic tests, and clinicopathological factors customarily evaluated by a qualified physician. ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; EML4, echinoderm microtubule-associated protein-like 4; ERCC1, excision repair cross complementing gene 1; KRAS, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; RRM1, ribonucleotide reductase M1 1 National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer (v3.2011); 2 Taguchi F, Solomon B, Gregorc V, et al. J Natl Cancer Inst. 2007;99(11): Carbone DP, Seymour L, Ding K, Roder H, Tsao M, Shepherd FA. Serum proteomic prediction of outcomes in advanced NSCLC patients treated with /placebo in the NCIC clinical trials group BR.21 trial. J Thorac Oncol. 2010;5(5)(suppl 1):S80 abstr The National Comprehensive Cancer Network (NCCN) has recommended that patients diagnosed with advanced NSCLC be tested for EGFR mutations and EML4/ALK fusions (biopsy specimens are required), and that in patients who test positive for EGFR mutations, be used in first-line. In patients who test positive for EML4/ALK fusions, crizotinib is a preferred first-line option. 13 Figure 2 shows a biomarker testing and treatment algorithm for first-line therapy based on histological and tissue-based mutation testing for EGFR mutation and EML4/ALK rearrangement. 13 These developments are encouraging for patients who test positive for EGFR mutations or EML/ALK fusions, but that group equals around only 20% of the total number of patients with advanced NSCLC. As shown in Figure 1, only about 15% of patients demonstrate EGFR mutations, and only about 5% are EML/ALK-positive. An important question remains: How are healthcare providers to manage the other 80%, particularly patients who test EGFR wild-type or have cancers with non-adenocarcinoma histology? Because the majority of NSCLC patients receive only two lines of therapy, it is critical that they receive the right therapy at the right time. 14 Is it possible to personalize their therapy in order to maximize outcomes? Proteomic test when considering either or single-agent chemotherapy Multiple treatment options are available for advanced or metastatic disease (see Table 2). Those options can be viewed differently if categorized by line of therapy (see Table 3). About 90% of patients with advanced NSCLC receive platinum-based therapy as first-line therapy. 14 Some, however, receive or single-agent chemotherapy (docetaxel, pemetrexed) in the first-line setting if they have poor performance status or are ineligible to receive platinum-based agents. Others receive or single agent chemotherapy in the second- and third-line settings. 13 Randomized phase 3 trials have shown median overall survivals of 6-8 months in patients with NSCLC treated in the second- or thirdline with these agents (see Table 4). is a commercially available serum proteomic test that has been validated in over 1500 patients with advanced NSCLC. 1,16 It is used when the NCCN recommended treatment options are or single-agent chemotherapy (see Figure 3). analyzes a small amount of the patient s serum to characterize its 3

4 Non-adenocarcinoma Histological testing Table 2. Therapeutic Options for Advanced NSCLC EGFR WT, EML/ALK-, status unknown Adenocarcinoma Chemotherapeutic Agents Targeted Therapies First-line therapy Platinumbased chemotherapy Tissue-based mutational testing EML/ALK+ Crizotinib EGFR+ Figure 2. Biomarker Testing and Treatment Algorithm for First-Line Therapy National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines Non-Small Cell Lung Cancer. V Available at: Retrieved April 16, Platinums Carboplatin Cisplatin Taxanes Vinorelbine Gemcitabine Antifolates Pemetrexed (Alimta, Eli Lilly) Anti-vascular endothelial growth factor (VEGF) Bevacizumab (Avastin, Genentech) EGFR TKIs Gefitinib (Iressa, AstraZeneca) not approved in the US EGFR antibodies Cetuximab (Erbitux, Pfizer) protein content. Depending on the patient s protein characterization, indicates if a patient is more likely ( Good) or less likely ( Poor) to benefit from treatment with an EGFR inhibitor, such as or gefitinib. Those patients likely to have poor outcomes might receive chemotherapy. The Clinical Evidence Eastern Co-operative Oncology Group (ECOG) 3503 was a trial of first-line provided to patients with advanced NSCLC. Patients were either ineligible for platinum-based National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines. Non-Small Cell Lung Cancer. V Available at: Retrieved April 16, doublets or chose not to receive them. All patients were retrospectively evaluated using. 16 As Table 5 shows, patients whose test results were Good had a median survival of 10.1 months and a one-year survival rate of 47%. Poor patients, however, had a median survival of 3.5 months and a one-year survival rate of 12%. 16 The Phase III Study BR.21 examined patients with ad- Table 3. Therapeutic Options for Advanced NSCLC by Line of Therapy First-Line Maintenance Second-Line Third-Line Cisplatin- or carboplatin-based combinations, including taxanes, gemcitabine, and vinorelbine Continuation maintenance (bevacizumab, cetuximab, pemetrexed* gemcitabine) Single-agent docetaxel, pemetrexed,* for EGFR mutation-positive patients Bevacizumab + chemotherapy* Cetuximab/vinorelbine/cisplatin Pemetrexed + cisplatin* Crizotinib (EML4/ALK positive patients) Switch maintenance (pemetrexed*, ) Platinum-based combination if or crizotinib given first line Best supportive care *Approved in non-squamous histology only National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines Non-Small Cell Lung Cancer. V Available at: Retrieved April 16,

5 Single-agent therapy options:, pemetrexed, docetaxel serum test Table 4. Median Overall Survival for Patients with NSCLC in Selected Trials Phase 3 Trial Regimen n TAX3201 Docetaxel Vinorelbine or Ifosfamide Median Overall Survival (months) Poor Good Alimta Registration Trial2 INTEREST3 Pemetrexed Docetaxel Gefinitib Docetaxel Consider options other than Consider Figure 3. The Role of Serum Test * test results should be used in combination with the patient s clinical history, other diagnostic tests, and clinicopathological factors customarily evaluated by a qualified physician. vanced NSCLC who were receiving second- or third-line. 1 Again, patient data were retrospectively analyzed (see Table 6). In this trial, the patients classified as Good had a median OS of 10.5 months and an estimated one-year survival of 42%. Poor patients had a median overall survival of four months, with an estimated one-year survival of 13%. 1 Together, ECOG 3503 and BR.21 show that patients classified as Good have better survival outcomes compared with patients classified as Poor when treated with. In both studies, was independent of EGFR mutations. This means that a patient s EGFR mutation status does not predict their status. Based on these data, testing is appropriate when considering versus single agent chemotherapy in the first, second or third line settings. What Does Mean for the Oncology Nurse? Patient Education: An essential role of the oncology nurse is patient education about the disease state and its implications and about selecting and managing therapy. Veristrat offers an opportunity for the oncology team to personalize therapy for patients, and the oncology nurse will be in the BR.21 Trial4 Placebo Fossella FV, Devore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol Jun;18(12): Hanna N, Shepherd FA, Fossella FV, et al., Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol May 1;22(9): Kim ES, Hirsh V, Mok T, et al. Gefitinib versus docetaxel in previously treated non-smallcell lung cancer (INTEREST): a randomised phase III trial. Lancet Nov 22;372(9652): Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. in Previously Treated Non Small-Cell Lung Cancer. N Engl J Med. 2005; 353: primary position to explain to patients what the test is, why it is needed, what it entails, and finally, what the results mean. Nurses will explain that is a blood-based test and is not a treatment for NSCLC. Rather, it provides additional information to help the healthcare team identify the best treatment. is a serum proteomic test, which looks at the characteristics of proteins in the serum. Nurses will tell patients that can provide guidance for therapy selection regardless of a patient s mutation status. 1 Further, nurses will point out that can help guide treatment selection for patients who: Have advanced NSCLC but are ineligible for platinumbased regimens Have advanced NSCLC but have progressed on previous therapy Nurses will want to point out the advantages of the test for the patient. Many patients with advanced NSCLC do not or cannot provide biopsy samples for other testing. In major phase 3 trials, on average, only 20%-30% of patients were 5

6 Table 5. Retrospective Analysis of ECOG 3503, First-line Patients with Advanced NSCLC Treated with Population n (%) Good Poor Median Overall Survival (months) One-Year Survival (%) 69 (72) (28) p = ; hazard ratio = 0.33 (95% confidence interval, ) Taguchi F, Solomon B, Gregorc V, et al. J Natl Cancer Inst. 2007;99: , data updated from publication. able to provide a tissue sample. 17 Noninvasive Veristrat does not require tissue samples and relies on a simple blood draw. Nurses will explain that can provide the healthcare team with as much information as possible to make the most appropriate treatment decision.. helps reduce trial-and-error or guesswork. Nurses will explain that can provide the healthcare team with crucial information in less than 72 hours, unlike other tissue-based tests.. may, therefore, help Table 6. Retrospective Analysis of BR.21, Second- and Third-line Patients with Advanced NSCLC Treated with Population n (%) Good + Poor + Median Overall Survival (months) One-Year Survival, (%) 183 (62.7) (37.3) p < ; hazard ratio = 0.37 (95% confidence interval = ) Carbone DP, Seymour L, Ding K, Roder H, Tsao M, Shepherd FA. Serum proteomic prediction of outcomes in advanced NSCLC patients treated with /placebo in the NCIC clinical trials group BR.21 trial. J Thorac Oncol. 2010;5(5)(suppl 1):S80 abstract reduce patient anxiety. For patients concerned about the cost of testing, nurses can point out that Veristrat typically costs less than one month s therapy with. In addition, Biodesix offers important patient assistance programs. Ease of Test Administration and Interpretation: The Veristrat test is performed using serum obtained from a standard blood draw. Thus, it is uncomplicated for nurses and can be incorporated into a regular office visit, and is convenient for the patient. No additional scheduling is required as the blood draw is usually conducted within the oncology practice office. The sample is sent to Biodesix for testing on the same day, and results are received within 72 hours. Results are easy to read ( Good or Poor) and easy to explain to the patient. Good patients are more likely to respond to, while Poor patients are not, and, as a result, the physician may decide to place the patient on alternatives to. Patient Support: Biodesix offers a patient assistance program to help all patients have access to the test. For patients on Medicare, Biodesix will file the claim and any needed appeals. For patients with private health insurance, Biodesix will file the claim and any needed appeals, but patients may be required to pay a co-payment, co-insurance, or deductible. However, Biodesix may reduce or eliminate those costs under their Financial Assistance Program. Biodesix will also provide at no cost to patients who qualify on the basis of financial need. Patients should call the Support Hotline at for information and assistance in applying for these programs. How Is the Test Ordered? collection and shipping kits can be ordered directly from Biodesix. Healthcare providers should call the Support Hotline at to place kit orders. Contents of the Kit The kit includes everything needed to collect, record, and submit samples: patient identification labels, an SST tube, a serum collection card, a foil return bag, and a Test Request Form. See Figure 4. Attach patient identification labels to the provided SST tube and draw 3 mls of blood Transfer the sample to a centrifuge and spin at 1,000-1,300 for minutes. Transfer 2 drops of serum to each circle on the serum collection card provided. Attach patient identification labels to the collection card and complete the Test Request Form. Seal the collection card into the foil bag and place it and the Test Request From back into the original collection kit package. Ship via FedEx using the airbill provided. Results will be received, via fax or , within 72 hours. 6

7 Figure 4. The Kit Summary EGFR mutation and EML4/ALK rearrangement tests can be critically useful for guiding first-line therapy for patients with advanced NSCLC. However, results of these tests can suggest targeted therapies for only relatively few patients. can offer valuable guidance to healthcare providers for the majority of their other patients with advanced NSCLC, specifically those patients who are ineligible for platinum-based therapy, or have experienced disease progression after other treatment, and are under consideration for treatment with single-agent or single agent chemotherapy such as docetaxel or pemetrexed. can differentiate among those patients who are most likely to respond to and whose who are not, and it can do so quickly. This rapid information can facilitate placing patients on the most appropriate therapy quicker, thereby potentially enhancing outcomes and relieving patient distress. Figure 5 presents a revised diagnostic and therapeutic algorithm for patients with advanced NSCLC. Discover How Can Help You Guide Therapy Simply call the Support Hotline at or visit and inform the customer service representative that you would like to begin testing. The customer service representative will assist you in accommodating your facility s needs, including shipment of test kits and training. This white paper was developed by ONS:Edge in collaboration with Biodesix. All content belongs to and is copyrighted by Biodesix. ONS:Edge assists with distribution and promotion. ONS:Edge participation in this project does not imply product endorsement. For more information about this paper or to download copies, visit ONS:Edge can be contacted by at or by phone at EDGE (3433) or References (1) Carbone DP, Seymour L, Ding K, Roder H, Tsao M, Shepherd FA. Serum proteomic prediction of outcomes in advanced NSCLC patients treated with /placebo in the NCIC clinical trials group BR.21 trial. J Thorac Oncol. 2010;5(5)(suppl 1):S80 abstr (2) Siegel R, Naishadaham D, Jemal A. Cancer statistics, CA: Cancer J Clinicians. 2012;62: (3) American Cancer Society (ACS). Lung Cancer (Non-Small Cell). Available at: Retrieved April 13, (4) Pao W, Girard N. New driver mutations in non-small-cell lung cancer. Lancet Oncol. 2011;12: (5) Kris MG,. Johnson BE, Kwiatkowski DJ, et al. Identification of driver mutations in tumor specimens from 1,000 patients with lung adenocarcinoma: The NCI s Lung Cancer Mutation Consortium (LCMC). J Clin Oncol. 29: 2011 (suppl; abstr CRA7506). (6) Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10): (7) Kobayashi K, Inoue A, Maemondo M, et al. First-line gefitinib versus first-line chemotherapy by carboplatin (CBDCA) plus paclitaxel (TXL) in non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: A phase III study (002) by North East Japan Gefitinib Study Group ). J Clin Oncol 2009;27(suppl abstr 8016).. (8) Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362(25): (9) Martelli M, Sozzi G, Hernandez L, et al. EML4-ALK rearrangement in non-small cell lung cancer and non-tumor lung tissues. Am J Path. 2009;172(2): (10) Shaw AT, Yeap BY, Mino-Kenudson M, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J Clin Oncol 2009;27(26): (11) Kwak EL, Bang YJ, Camidge DR,et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med.2010;363:

8 Non-adenocarcinoma Histological testing EGFR testing EGFR or status unknown (insufficient tissue) Platinum-based chemotherapy Adenocarcinoma EGFR+ (12) Bang Y, Kwak EL, Shaw AT, et al. Clinical activity of the oral ALK inhibitor PF in ALK-positive patients with non-small cell lung cancer (NSCLC). J Clin Oncol. 2010;28 (suppl abstr 3). (13) National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines Non-Small Cell Lung Cancer. V Available at: Retrieved April 16, (14) CancerMPact, Kantar Health. US, (15) Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. in previously treated non-small-cell lung cancer. N Engl J Med. 2005;353: (16) Taguchi F, Solomon B, Gregorc V, et al. J Natl Cancer Inst. 2007;99(11): (Updated data from publication) (17) Soria JC. Application and limitation of biomarker analysis: session discussion. Presented at: 44th ASCO Annual Meeting; May 30-June 3, 2008; Chicago, IL. Ineligible for Platinum-based chemotherapy DISEASE PROGRESSION Single-agent therapy options:, pemetrexed, docetaxel Therapy options:, pemetrexed, docetaxel serum test Poor Good Consider options other than Consider Figure 5. Incorporating Testing into Advanced NSCLC Patient Management 8

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