385P - Patient reported outcomes (PROs) analysis for patients with ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) receiving entrectinib in the global phase II STARTRK-2 study

Background

In the ongoing STARTRK-2 study (NCT02568267), entrectinib demonstrated a favourable efficacy and safety profile in patients with locally advanced/metastatic ROS1+ NSCLC. We present the results of a pre-specified PRO analysis in an updated dataset with longer follow-up.

Methods

The European Organization for Research and Treatment of Cancer quality of life questionnaire (QLQ-C30), and lung cancer module (QLQ-LC13) were completed prior to entrectinib dosing on Day 1 of every treatment cycle, and at end of treatment. The safety analysis set (SAS; patients received ≥1 entrectinib dose) was used to assess treatment-related symptoms. The efficacy analysis set (EAS; SAS patients with measurable baseline disease) was used to assess tumor-related symptoms, functioning, and global health status (GHS).

Results

At the data cut-off (1 May 2019), the SAS and EAS included 180 and 145 patients, respectively. GHS and functioning scores were maintained or improved during treatment, with the exception of cognitive functioning (Table). Tumor-related symptoms remained stable or trended towards improvement over time. For treatment-related symptoms, insomnia and appetite loss improved, while constipation and diarrhea worsened.

Conclusions

Among ROS1+ NSCLC patients, the treatment burden associated with entrectinib was minimal. There was a trend towards improved physical and role functioning, GHS, and tumor-related symptoms (particularly cough) while receiving entrectinib Table: 385P

*Clinically meaningful change from baseline: >10 points. ^†Last cycle with ≥25% patient enrollment. ^‡Occupational/social. Higher scores indicate improvement for GHS and functioning, worsening for symptom scales.

Clinical trial identification

STARTRK-2 study: NCT02568267.

Editorial acknowledgement

Alix Biancardi, Gardiner-Caldwell Communications.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

F. Barlesi: Advisory/Consultancy, Personal finance interests: AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F Hoffmann-La Roche, Novartis, Merck, MSD, Pierre Fabre, Pfizer, and Takeda; Research grant/Funding (institution): AbbVie, ACEA, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eisai, Eli Lilly Oncology, F Hoffmann-La Roche, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Novartis, MedImmune, Merck, Merck Sharp and Dohme, Pierre Fabre, Pfizer; Research grant/Funding (institution): Sanofi-Aventis, Takeda. J. Wolf: Advisory/Consultancy: Amgen, AstraZeneca, Bayer, Blueprint, BMS, Boehringer-Ingelheim, Chugai, Daiichi Sankyo, Ignyta, Janssen, Lilly, Loxo, MSD, Novartis, Pfizer, Roche, Seattle Genetics, Takeda; Research grant/Funding (institution): MSD, BMS, Janssen Pharmaceutica, Novartis, Pfizer. M-J. Ahn: Honoraria (institution): AstraZeneca, Lilly, Takeda, Roche, MSD; Advisory/Consultancy: AstraZeneca, Lilly, Takeda, Roche, MSD, Merck, Boehringer Ingelheim, Ono Pharmaceutical, Bristol-Myers Squibb, and Alpha Pharmaceutical, Progeneer. R.C. Doebele: Advisory/Consultancy: Ignyta, Genentech/Roche, Loxo Oncology, Bayer, Eli Lilly, AstraZeneca, Pfizer, Blueprint Medicines, Anchiano, Rain Therapeutics; Research grant/Funding (institution): Ignyta, Loxo, Mirati, Pfizer, Eli Lilly, Strategia; Travel/Accommodation/Expenses: Ignyta, Genentech/Roche, Eli Lilly, Pfizer, Blueprint Medicines, Rain Therapeutics; Shareholder/Stockholder/Stock options: Rain Therapeutics; Licensing/Royalties: Ignyta, Loxo, Abbott Molecular, Genentech/Roche, Chugai, Foundation Medicine, Black Diamond, Rain Therapeutics, Voronoi, Pearl River, Ariad (patent and biologic material licensing fees). L. Paz-Ares: Advisory/Consultancy: Genentech/Roche, Loxo Oncology, Bayer, Eli Lilly, AstraZeneca, Pfizer, Bayer, Merck Sharp & Dohme, Novartis, Amgen, Pharmamar, Boehringer Ingelheim, Celgene, Servier, Sysmex, Incyte, Ipsen, Adacap, Sanofi, Blueprint Medicines; Research grant/Funding (institution): BMS, AstraZeneca, Merck Sharp & Dohme; Shareholder/Stockholder/Stock options: Altum Sequencing; Officer/Board of Directors: Genomica, Altum Sequencing. C. Rolfo: Advisory/Consultancy: Mylan, Oncompass, Archer, Inivata, MD Serono; Leadership role: IASLC Educational Committee Member and LATAM (IASLC) co-chair, ESO Scientific Committee Board, ISLB Vice president and Educational Chair, Educational Chair OLA; Research grant/Funding (institution): Biomarkers, Guardant Health (Research collaboration) Lung Cancer Research Foundation-Pfizer Grant, American Cancer Society grant, PY30 NIH grant. S. Siena: Advisory/Consultancy: Amgen, Payer, CheckMab, Celgene, Daiichi Sankyo, Incyte, Merck, Novartis, Roche, Seattle Genetics. T. Seto: Honoraria (institution): Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Kyowa Hakko Kirin, MSD, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical, Takeda Pharmaceutical; Research grant/Funding (institution): AbbVie, AstraZeneca, Bayer Yakuhin, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Kissei Pharmaceutical, Loxo Oncology, Merck Serono, MSD, Nippon, Boehringer Ingelheim, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical; Full/Part-time employment: Precision Medicine Asia; Honoraria (institution): Thermo Fisher Scientific. Y. Ohe: Honoraria (institution): AstraZeneca, Chugai, Eli Lilly, ONO, BMS, Boehringer Ingelheim, Bayer, Pfizer, MSD, Taiho, Nippon Kayaku, Kyowa Hakko Kirin; Advisory/Consultancy: AstraZeneca, Chugai, ONO, BMS, Kyorin, Celltrion, Amgen, Nippon Kayaku; Research grant/Funding (institution): AstraZeneca, Chugai, Lilly, ONO, BMS, Kyorin, Dainippon-Sumitomo, Pfizer, Taiho, Novartis, Kissei, Ignyta, Takeda, Kissei, Daiichi-Sankyo, Janssen, LOXO. S.H.I. Ou: Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer, Roche/Genentech, AstraZeneca, Takeda/ARIAD, Daiichi Sankyo; Research grant/Funding (institution): Pfizer, Roche/Genentech, AstraZeneca, Takeda/ARIAD, Daiichi Sankyo, Janssen, Mirati, Revolution Medicine, Lilly/Loxo Oncology, BluePrint Medicine; Shareholder/Stockholder/Stock options: Turning Point Therapeutics. M.G. Krebs: Honoraria (institution): Roche; Advisory/Consultancy: Roche, Janssen, Octimet, Achilles Therapeutics; Speaker Bureau/Expert testimony: Roche; Research grant/Funding (institution): AstraZeneca, Bayer, BerGenBio, Blueprint, BMS, Carrick, CellCentric, Chugai, Debiopharm, Genmab, Immutep, Incyte, Janssen, Kymab, Lilly, MedImmune, Merck, MSD, Novartis, Octimet, Roche, Sierra, StarPharma, Taiho, Turning Point Therapeutics; Travel/Accommodation/Expenses: AstraZeneca, BerGenBio; Research grant/Funding (self): Roche, BerGenBio. A. Kapre: Full/Part-time employment: Genentech/Roche. E. Piault-Louis: Full/Part-time employment: Genentech/Roche. S. McCallum: Full/Part-time employment: Genentech/Roche. S. Osborne, A. Aziez: Full/Part-time employment: Roche. A. Drilon: Honoraria (institution): Ignyta/Roche/Genentech, Loxo/Bayer/Lily, TP Therapeutics, AstraZeneca, Pfizer, Blueprint, Takeda/Ariad/Millennium, Helsinn, BeiGene, BerGenBio, Hengrui, Exelixis, Tyra, Verastem, MORE Health, AbbVie, 14ner/Elevation Oncology, Axis, Peerview Institute; Licensing/Royalties: Wolters Kluwer; Research grant/Funding (institution): Foundation Medicine, Pfizer, Exelixis, Taiho, Teva, GlaxoSmithKline, Pharmamar; Honoraria (institution): OncLive, Paradigm Medical Communications, Remedica Ltd., ArcherDX, Foundation Medicine, PeerVoice, Research to Practice, Medscape, WebMD.