The non-small cell lung cancer pipeline is growing as a result of a rise d understanding of the disease’s heterogeneity, which has led to the development of personalized therapies targeting distinct patient subtypes. The success of these personalized therapies is likely to incentivize pharmaceutical industry players to continue developing targeted therapies for niche patient populations.Analysis of industry ed NSCLC drugs – development history, key clinical trial data, and assessment of clinical and commercial attractivenessAnalysis of industry ed drugs in comparison to current standard of careIn-depth analysis of late-stage pipeline drugs – development overview, SWOT analysis, and assessment of clinical and commercial attractivenessDiscussion and assessment of pipeline drugs’ ability to meet unmet needs in treatment of non-small cell lung cancerPipeline drugs such as Bristol-Myers Squibb’s Erbitux (cetuximab) and Roche’s MetMab (onartuzumab) are currently being trialed in combination with platinum chemotherapy and Avastin respectively. Roche will inevitably benefit if MetMab is approved in this setting given Avastin’s already established physician familiarity and high uptake.Targeted therapies maintain competition for greater industry share. Avastin remains dominant, particularly in the US, but Tarceva (erlotinib), Iressa (gefitinib) and Xalkori (crizotinib) will increase pressure on Avastin given that their use in specific patient subsets avoids exposing unsuitable patients to unnecessary side-effects.Targeted and immunotherapeutic drugs dominate the late-stage pipeline. Lucanix (belagenpumatucel-L) and Stimuvax (BLP-25) are the most advanced immunotherapies in the pipeline, looking set to enter the industry in the second-line and maintenance settings respectively. No immunotherapies are currently approved for non-small cell lung cancer.Understand the dynamics of non-small cell lung cancer therapy and identify the industry leaders in this competitive indication.Compare and assess current late-stage pipeline drugs according to industry positioning, commercial potential and clinical efficacy.Understand how pipeline drugs will be used with current therapies and how the industry is accessed through less competitive treatment settings.

Table Of Contents


OVERVIEW•Catalyst
•Summary

EXECUTIVE SUMMARY•Strategic scoping and focus
• Datamonitor key findings
•Related reports

PRODUCT OVERVIEW•Key industry ed and pipeline drugs

MARKETED PRODUCT PROFILES: MOLECULAR TARGETED THERAPIES•Avastin (bevacizumab; Roche/Genentech/Chugai) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness
- Biomarkers need to be validated if Avastin is to maintain its position
- Indication expansions in NSCLC a struggle

•Iressa (gefitinib; AstraZeneca) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Tarceva (erlotinib; Genentech/Roche/Chugai/OSI) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Xalkori (crizotinib; Pfizer) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

PIPELINE PRODUCT PROFILES: CYTOTOXICS•Halaven (eribulin; Eisai) - Drug overview
- Drug presentation
- Drug pipeline analysis
- Demonstrated activity in taxane sensitive NSCLC
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

PIPELINE PRODUCT PROFILES: IMMUNOTHERAPIES•GSK1572932A (astuprotimut-r; GlaxoSmithKline) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Lucanix (belagenpumatucel-L; NovaRx) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Stimuvax (BLP 25; Oncothyreon) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Talactoferrin (Agennix) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Yervoy (ipilimumab; Bristol Myers Squibb) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

PIPELINE PRODUCT PROFILES: MOLECULAR TARGETED THERAPIES•Dacomitinib (PF-00299804; Pfizer) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Erbitux (cetuximab; Bristol-Myers Squibb) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Ganetespib (STA-9090; Synta) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•MetMAb (onartuzumab; Roche) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Ramucirumab (IMC-1121B; ImClone/Eli Lilly) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Tivantinib (ARQ 197; ArQule) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Tomtovok (afatinib; Boehringer Ingelheim) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Votrient (pazopanib; GlaxoSmithKline) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•XL 647 (Exelexis) - Drug overview
- Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

BIBLIOGRAPHY•Journal papers
•Websites
•Datamonitor reports

APPENDIX •Market definition
•PharmaVitae Explorer databasePlease visit the
•Conferences attended
•Report methodology

TABLES•Table: Key industry ed products for non-small cell lung cancer, 2012
•Table: Key pipeline products for non-small cell lung cancer, 2012
•Table: Avastin (bevacizumab; Roche/Genentech/Chugai) approved indications, 2012
•Table: Avastin (bevacizumab; Roche/Genentech/Chugai) - drug presentation, 2012
•Table: Overview of pivotal trial data for Avastin (bevacizumab; Roche/Genentech/Chugai) in NSCLC
•Table: Datamonitor’s drug assessment summary for Avastin (Roche/Genentech/Chugai) in NSCLC, 2012
•Table: Iressa (gefitinib; AstraZeneca) - drug presentation, 2012
•Table: Iressa: key historical events, 1997-2010
•Table: Datamonitor’s drug assessment summary for Iressa (gefitinib; AstraZeneca) in NSCLC, 2012
•Table: Tarceva (erlotinib; Genentech/Roche/Chugai/OSI) - drug presentation, 2012
•Table: Overview of pivotal trial data for Tarceva (erlotinib; Genentech/Roche/Chugai/OSI) in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for Tarceva (erlotinib; Genentech/Roche/Chugai/OSI) in NSCLC, 2012
•Table: Xalkori (crizotinib; Pfizer) - drug presentation, 2012
•Table: Overview of pivotal trial data for Xalkori (crizotinib; Pfizer) in NSCLC, 2011
•Table: Datamonitor’s drug assessment summary for Xalkori (crizotinib; Pfizer) in NSCLC, 2012
•Table: Halaven (eribulin; Eisai) - drug presentation, 2012
•Table: Clinical development of Halaven (eribulin; Eisai) in NSCLC, 2012
•Table: Ability of Halaven (eribulin; Eisai) to meet unmet needs in NSCLC, 2012
•Table: GSK1572932A (astuprotimut-r; GlaxoSmithKline) - drug presentation, 2012
•Table: Clinical development of GSK1572932A (astuprotimut-r; GlaxoSmithKline) in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for GSK1572932A (astuprotimut-r; GlaxoSmithKline) in NSCLC, 2012
•Table: Lucanix (belagenpumatucel-L; NovaRx) - drug presentation, 2012
•Table: Ongoing clinical development of Lucanix (belagenpumatucel-L; NovaRx) in NSCLC, 2012
•Table: Ability of Lucanix to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for Lucanix (belagenpumatucel-L; NovaRx) in NSCLC, 2012
•Table: Stimuvax (BLP 25; Oncothyreon) - drug presentation, 2012
•Table: Ongoing clinical development of Stimuvax (BLP 25; Oncothyreon) in NSCLC, 2012
•Table: Ability of Stimuvax to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for Stimuvax (BLP 25; Oncothyreon) in NSCLC, 2012
•Table: Talactoferrin (Agennix) - drug presentation, 2012
•Table: Ongoing clinical development of talactoferrin (Agennix) in NSCLC, 2012
•Table: Ability of talactoferrin (Agennix) to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for talactoferrin (Agennix) in NSCLC, 2012
•Table: Yervoy (ipilimumab; Bristol-Myers Squibb) - drug presentation, 2011
•Table: Ongoing clinical development of Yervoy (Ipilimumab; Bristol-Myers Squibb) in NSCLC, 2012
•Table: Ability of Yervoy to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for Yervoy (ipilimumab; Bristol-Myers Squibb) in NSCLC, 2012
•Table: Dacomitinib (PF-00299804; Pfizer) - drug presentation, 2012
•Table: Ongoing clinical development of dacomitinib (PF-00299804; Pfizer) in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for dacomitinib (PF-00299804; Pfizer) in NSCLC, 2012
•Table: Erbitux (cetuximab; Bristol Myers Squibb) - drug presentation, 2012
•Table: Ongoing clinical development of Erbitux (cetuximab; Bristol Myers Squibb) in NSCLC, 2012
•Table: Ability of Erbitux to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for Erbitux (cetuximab; Bristol-Myers Squibb) in NSCLC, 2012
•Table: Ganetespib (STA-9090; Synta) - drug presentation, 2012
•Table: Ongoing clinical development of ganetespib (STA;9090; Synta) in NSCLC, 2012
•Table: Ability of ganetespib to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for ganetespib (STA;9090; Synta) in NSCLC, 2012
•Table: MetMAb (onartuzumab; Roche) - drug presentation, 2012
•Table: Ongoing clinical development of MetMAb (onartuzumab; Roche) in NSCLC, 2012
•Table: Ability of MetMAb to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for MetMAb (onartuzumab; Roche) in NSCLC, 2012
•Table: Ramucirumab (IMC-1121B; ImClone/Eli Lilly) - drug presentation, 2012
•Table: Ongoing clinical development of ramucirumab (IMC-1121B; ImClone/Eli Lilly) in NSCLC, 2012
•Table: Ability of ramucirumab to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for ramucirumab (IMC-1121B; ImClone/Eli Lilly) in NSCLC, 2012
•Table: Tivantinib (ARQ 197; ArQule) - drug presentation, 2012
•Table: Ongoing clinical development of tivantinib (ARQ 197; ArQule) in NSCLC, 2012
•Table: Ability of tivantinib to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for tivantinib (ARQ 197; ArQule) in NSCLC, 2012
•Table: Tomtovok (afatinib; Boehringer Ingelheim) - drug presentation, 2012
•Table: Ongoing clinical development of Tomtovok (afatinib; Boehringer Ingelheim) in NSCLC, 2012
•Table: Ability of Tomtovok to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for Tomtovok (afatinib; Boehringer Ingelheim) in NSCLC, 2012
•Table: Votrient (pazopanib; GlaxoSmithKline) - drug presentation, 2012
•Table: Ongoing clinical development of Votrient (pazopanib; GlaxoSmithKline), 2012
•Table: Ability of Votrient to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary Votrient (pazopanib; Pfizer) in NSCLC, 2012
•Table: XL 647 (Exelexis) - drug presentation, 2012
•Table: Ongoing clinical development of XL 647 (Exelexis) in NSCLC, 2012
•Table: Ability of XL 647 (Exelexis) to meet unmet needs in NSCLC, 2012
•Table: Datamonitor’s drug assessment summary for XL 647 (Exelexis) in NSCLC, 2012
•Table: Summary of therapeutic classes used for osteoporosis by ATC code, 2011

FIGURES•Figure: SWOT analysis for Avastin (bevacizumab; Roche/Genentech/Chugai) in NSCLC, 2012
•Figure: Datamonitor’s drug assessment summary for Avastin (bevacizumab; Roche/Genentech/Chugai) in NSCLC, 2012
•Figure: SWOT analysis for Iressa (gefitinib;AstraZeneca/Teva) in NSCLC, 2012
•Figure: Datamonitor’s drug assessment summary for Iressa (gefitinib; AstraZeneca) in NSCLC, 2012
•Figure: SWOT analysis for Tarceva (erlotinib; Genentech/Roche/Chugai/OSI) in NSCLC, 2012
•Figure: Datamonitor’s drug assessment summary for Tarceva (erlotinib; Genentech/Roche/Chugai/OSI) in NSCLC, 2012
•Figure: SWOT analysis for Xalkori (crizotinib; Pfizer) in NSCLC, 2012
•Figure: Datamonitor’s drug assessment summary for Xalkori (crizotinib; Pfizer) in NSCLC, 2012
•Figure: Phase II results for Halaven (eribulin; Eisai) in taxane-sensitive and resistant NSCLC, 2012
•Figure: SWOT analysis for Halaven (eribuliln; Eisai) in NSCLC, 2012
•Figure: SWOT analysis for GSK1572932A (astuprotimut-r; GlaxoSmithKline) in NSCLC, 2012
•Figure: Datamonitor’s drug assessment summary for GSK1572932A (astuprotimut-r; GlaxoSmithKline) in NSCLC, 2012
•Figure: Phase II results for Lucanix (belagenpumatucel-L; NovaRx) in advanced NSCLC
•Figure: Lucanix (belagenpumatucel-L;NovaRx) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for Lucanix (belagenpumatucel-L; NovaRx) in NSCLC, 2012
•Figure: Phase IIB results for Stimuvax (BLP 25; Oncothyreon) maintenance therapy in advanced NSCLC
•Figure: Stimuvax (BLP 25; Oncothyreon) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for Stimuvax (BLP 25; Oncothyreon) in NSCLC, 2012
•Figure: Talactoferrin (Agennix) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for talactoferrin (Agennix) in NSCLC, 2012
•Figure: Phase II randomized trialing of Yervoy in Stage IIIB/IV NSCLC
•Figure: Yervoy (ipilimumab; BristolMyersSquibb) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for Yervoy (ipilimumab; Bristol-Myers Squibb) in NSCLC, 2012
•Figure: Dacomitinib (PF-00299804; Pfizer) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for dacomitinib (PF-00299804; Pfizer) in NSCLC, 2012
•Figure: Erbitux (cetuximab; Bristol Myers Squibb) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for Erbitux (cetuximab; Bristol-Myers Squibb) in NSCLC, 2012
•Figure: Ganetespib (STA;9090; Synta) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for ganetespib (STA;9090; Synta) in NSCLC, 2012
•Figure: MetMAb in Met positive patients following failure of at least one prior chemotherapy
•Figure: MetMab (onartuzumab; Roche) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for MetMAb (onartuzumab; Roche) in NSCLC, 2012
•Figure: Phase II results for ramucirumab (IMC-1121B; ImClone/Eli Lilly) with chemotherapy in first-line advanced NSCLC
•Figure: Ramucirumab (IMC-1121B; ImCllone/Eli Lilly) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for ramucirumab (IMC-1121B; ImClone/Eli Lilly) in NSCLC, 2012
•Figure: Tivantinib (ARQ 197; ArQule) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for tivantinib (ARQ 197; ArQule) in NSCLC, 2012
•Figure: Phase II results for Tomtovok (afatinib; Boehringer Ingelheim) in first- or second-line Stage IIIB/IV lung adenocarcinoma in patients with activating EGFR mutations
•Figure: Tomtovok (afatinib; Boehringer Ingelheim) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for Tomtovok (afatinib; Boehringer Ingelheim) in NSCLC, 2012
•Figure: Votrient (pazopanib; GlaxoSmithKline) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for Votrient (pazopanib; Pfizer) in NSCLC, 2012
•Figure: Phase II trial of XL 647 (Exelexis) in patients who have previously responded to gefitinib or erlotinib
•Figure: XL 647 (Exelexis) SWOT analysis, 2012
•Figure: Datamonitor’s drug assessment summary for XL 647 (Exelexis) in NSCLC, 2012
•Figure: The PharmaVitae Explorer

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27 Apr 2012

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Anheuser-Busch InBev SA/NV, Eli Lilly and Firms, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Merck KGaA, Pfizer Inc., QIAGEN N.V.

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