ASCO 2013: Boehringer Ingelheim to present highly anticipated new Phase III results for front-runner compounds afatinib* and nintedanib* in first- and second-line NSCLC treatment
- Three of the company’s investigational compounds, targeting different pathways and distinct patient populations, will be included in 14 data presentations
- Four abstracts accepted for oral presentation – spanning advanced non-small cell lung cancer (NSCLC), renal cell carcinoma, head and neck squamous cell carcinoma and ovarian cancer
Ingelheim, Germany, 16 May 2013 – Boehringer Ingelheim today announced the upcoming presentation of data from 14 abstracts involving three of the company’s investigational oncology compounds – afatinib*, nintedanib* and volasertib*. Results, to be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, 31 May - 4 June, 2013, are from Boehringer Ingelheim’s robust oncology pipeline. These data presentations demonstrate the company’s ongoing commitment to improving patients’ lives through the research and development of new treatment options, based on the latest advances in the field of oncology.
Data include new results from two pivotal Phase III trials of nintedanib* and new Phase III results for afatinib* across different advanced non-small cell lung cancer (NSCLC) subtypes:
- The LUME-Lung 1 trial (abstract #LBA8011): Phase III pivotal trial data evaluating nintedanib* in combination with standard second-line chemotherapy (docetaxel) in patients with advanced NSCLC after failure of first-line chemotherapy. This presentation was accepted as a late-breaker.
- The LUME-Lung 2 trial (abstract #8034): evaluating nintedanib* in combination with standard chemotherapy (pemetrexed) in patients with advanced NSCLC after failure of first-line chemotherapy.
- The LUX-Lung 6 trial, the largest prospective registration trial in EGFR mutation positive lung cancer patients, (abstracts #8016 & 8061): evaluating afatinib* compared to a standard chemotherapy (gemcitabine and cisplatin) as first-line treatment in Asian patients with advanced NSCLC who have an epidermal growth factor receptor (EGFR) mutation.
Dugi
"We are excited to present data from three of our proprietary late stage development compounds in four different cancer indications, which underlines our determination to advance therapies in oncology," said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Our extensive research programme is an expression of our dedication to improving outcomes for cancer patients through targeted treatment."
Presentations of Boehringer Ingelheim Investigational Oncology Compounds
A full listing of the nintedanib*, afatinib* and volasertib* abstracts included in the 2013 ASCO programme is below:
| Title | Authors | Abstract Details |
|---|---|---|
| Nintedanib* | ||
| LUME-Lung 1: Nintedanib (BIBF 1120) + docetaxel in NSCLC patients progressing after one prior chemotherapy regimen: results of LUME-Lung 1, a randomized, double-blind, phase 3 trial | Reck M, Kaiser R, Mellemgaard A, Douillard J-Y, Orlov S, Krzakowski M, von Pawel J, Gottfried M, Bondarenko I, Liao M, Barrueco J, Gaschler-Markefski B, Novello S | Oral Presentation Abstract #: LBA8011 Session: Clinical Science Symposium: Targeted Therapies in Lung Cancer: What's New and What's Enough? Date: Monday, 03 June Time: 10:45 – 11:00 Location: E Hall D2 |
| LUME-Lung 2: A multicenter, randomized, double-blind, phase 3 study of nintedanib plus pemetrexed vs placebo plus pemetrexed in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after failure of first-line chemotherapy | Hanna N, Kaiser R, Sullivan R, Aren O, Ahn MJ, Tiangco B, Zvirbule Z, Barrios CE, Demirkazik A, Gaschler-Markefski B, Voccia I, Barrueco J, Kim HJ |
Poster Discussion Abstract #: 8034 Session: Lung Cancer - Non-small cell metastatic Date: Sunday, 02 June Time: 08:00 - 12:00 Location: E450b Poster Board #: 23 Poster Discussion Time: 11:30 -12:30 Location: E354a |
| Safety and efficacy of nintedanib (BIBF 1120) plus pemetrexed in Japanese patients with advanced or recurrent non-small cell lung cancer (NSCLC): a phase I study | Daga H, Takeda K, Okada H, Miyazaki M, Ueda S, Kaneda H, Okamoto I, Yoh K, Goto K, Konishi K, Sarashina A, Yagi N, Mera K, Kaiser R, Nakagawa K | Poster Abstract #: 8056 Session: Lung Cancer – Non-small cell metastatic Date: Saturday, 01 June Time: 08:00 - 11:45 Location: S Hall A2 Poster Board #: 34D |
| Phase II efficacy and safety study of nintedanib vs sunitinib in previously untreated renal cell carcinoma (RCC) patients | Eisen T, Shparyk Y, Jones R, Macleod N, Temple G, Finnigan H, Kaiser R, Studeny M, Loembé AB, Bondarenko I | Oral presentation Abstract #: 4506 Session: Genitourinary (Non-prostate) Cancer Date: Saturday, 01 June Time: 15:00 – 15:15 Location: E Arie Crown Theater |
| Trials in Progress: Open-label, Phase I / randomized, Phase II trial of the triple angiokinase inhibitor, nintedanib, versus sorafenib in previously untreated patients with advanced hepatocellular carcinoma (HCC) | Palmer D, Peck-Radosavljevic M, Ting Ma Y, Graham J, Fartoux L, Hubner R, Loembé AB, Studeny M, Hocke J, Meyer T | Poster Abstract #: TPS4160 Session: Gastrointestinal (Non-colorectal) Cancer Date: Sunday, 02 June Time: 08:00 - 11:45 Location: S Hall A2 Poster Board #: 33F |
| Phase II Trial of Triple Receptor Tyrosine Kinase Receptor Inhibitor Nintedanib (BIBF 1120) in Recurrent High-Grade Gliomas | Norden AD, Schiff D, Ahluwalia MS, Lesser GJ, Nayak L, Lee EQ, Muzikansky A, Fadul CE, Dietrich J, Smith KH, Gaffey SC, McCluskey C, Ligon KL, Reardon DA, Wen PY | Poster Abstract #: TPS2104 Session: Central Nervous System Tumors Date: Saturday, 01 June Time: 08:00 – 11:45 Location: S Hall A2 Poster Board #: TBC |
| Title | Authors | Abstract Details |
|---|---|---|
| Afatinib* | ||
| LUX-Lung 6: A randomized, open-label, Phase III study of afatinib (A) vs gemcitabine/cisplatin (GC) as first-line treatment for Asian patients (pts) with EGFR mutation-positive (EGFR M+) advanced adenocarcinoma of the lung |
Wu Y-L, Zhou C, Hu C-P, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Lee KY, Massey D, Shi Y, Chen J, Geater SL | Poster Discussion Abstract #: 8016 Session: Lung Cancer—non-small nell metastatic Date: Sunday, 02 June Time: 08:00 -12:00 Poster Discussion Information Date: Sunday, 02 June Time: 11:30 -12:30 Poster Board #: 5 |
| LUX-Lung 6: Patient reported outcomes (PROs) from a randomized open-label, Phase III study in 1st-line advanced NSCLC patients (pts) harboring epidermal growth factor receptor (EGFR) mutations |
Geater S L, Zhou C, Hu C P, Feng J, Lu S, Huang Y, Li W, Hou M, Shi J H, Lee K Y, Massey D, Lungershausen J, Shi Y, Zazulina V, Wu Y L, | Poster Abstract #: 8061 Session: Lung Cancer - Non-small cell metastatic Date: Saturday, 01 June Time: 08:00 - 11:45 Poster Board #: 35A |
| Phase II study of afatinib, an irreversible ErbB Family Blocker, in demographically and genotypically defined non-small cell lung cancer (NSCLC) patients |
De Grève J, Moran T, Graas M-P, Galdermans D, Vuylsteke P, Canon J-L, Chand V, Fu Y, Massey D, Vansteenkiste JF | Poster Abstract #: 8063 Session: Lung Cancer - Non-small cell metastatic Date: Saturday, 01 June Time: 08:00 - 11:45 Poster Board #: 35C |
| A randomized, open-label, Phase II study of afatinib vs cetuximab in patients (pts) with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Analysis of Stage 2 (S2) following crossover | Cupissol D, Seiwert T, Fayette J, Ehrnrooth E, Blackman A, Cong XJ, Cohen E | Oral Presentation Abstract #: 6001 Session: Oral Abstract Session: Head and Neck Cancer Date: Sunday, 02 June Time: 08:00 - 11:00 |
| A Phase I, dose-escalation trial of continuous and pulsed-dose afatinib (A) combined with pemetrexed (P) in patients (pts) with advanced solid tumors: Final analysis | Chu QS-C, Sangha R, Hotte SJ, Sergenson G, Chand V, Sufan R, Gu Y, Schnell D, Hirte H | Poster Discussion Abstract #: 2523 Session Title: Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics Date: Tuesday, 04 June Time: 08:00 - 12:00 Poster Discussion Information Date: Tuesday, 04 June Time: 11:30 - 12:30 Poster Board #: 11 |
| Title | Authors | Abstract Details |
|---|---|---|
| Volasertib* | ||
| A phase I dose escalation study of volasertib (BI 6727) combined with nintedanib (BIBF 1120) in advanced solid tumors |
De Braud F, Cascinu S, Spitaleri G, Pilz K, Clementi L, Liu D, Glomb P, De Pas T | Poster Abstract #: 2556 Session: Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics Date: Monday, 03 June Time: 08:00 - 11:45 Location: S Hall A2 Poster Board #: 3H |
| Phase I study of volasertib (BI 6727) combined with afatinib (BIBW 2992) in advanced solid tumors |
Peeters M, Machiels JP, De Smet M, Pilz K, Strelkowa N, Liu D, Rottey S | Poster Discussion Abstract #: 2521 Session: Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics Date: Tuesday, 04 June Time: 08:00 - 12:00 Location: E450a Poster Board #: 9 Poster Discussion Time: 11:30 -12:30 Location: E354b |
| Randomized phase II trial of the Polo-like kinase (Plk) inhibitor volasertib (V) versus investigator’s choice chemotherapy in patients (pts) with platinum-resistant/refractory ovarian cancer (OC) | Pujade-Lauraine E, Weber B, Ray-Coquard I-L, Tschoepe I, Vergote I, Selle F, Del Campo JM, Sufliarsky J, Garin-Chesa P, Pilz K, Nazabadioko S, Joly F | Oral Presentation Abstract #: 5504 Session: Gynecologic Cancer Date: Saturday, 01 June Time: 16:15 – 16:30 Location: E354b |
Notes to Editors
About Afatinib*
Afatinib* is an irreversible ErbB Family Blocker which irreversibly blocks EGFR (ErbB1) as well as the other relevant members of the ErbB Family that are known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast and head & neck cancers). Afatinib* is currently in Phase III clinical development in NSCLC and head & neck cancer.
Afatinib* has been submitted to the FDA, EMA and regulatory authorities in Asia and other countries for treatment of EGFR mutation-positive locally advanced and metastatic NSCLC patients. Afatinib* received priority review status in the US.
About Nintedanib*
Nintedanib* is a triple angiokinase inhibitor that blocks three growth factor receptors simultaneously: vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR alpha and beta) and fibroblast growth factor receptors (FGFR 1-3).1 All three receptors are crucially involved in the formation and maintenance of new blood vessels (angiogenesis); their blockade may lead to the inhibition of angiogenesis, which plays a critical role in tumour growth and spread.2,3
Nintedanib* is currently being investigated in patients with a number of various solid tumours including advanced NSCLC, ovarian cancer, liver cancer (hepatic cell carcinoma), kidney cancer (renal cell carcinoma) and colorectal cancer.
About Volasertib*
Volasertib*, a selective and potent polo-like kinase inhibitor (Plk), is currently being evaluated in clinical trials for acute myeloid leukemia (AML) and is one of several late-stage compounds that Boehringer Ingelheim is currently evaluating in clinical trials for cancer.
Of the company’s ongoing research in cell cycle inhibition, the volasertib* clinical development programme is the furthest advanced. Volasertib* is first in class to reach Phase III clinical development.
Volasertib* is designed to inhibit the activity of Plk. Plk1 – the best characterised of the five known human Plks – is an enzyme that regulates cell division (mitosis). This inhibition results in cell-cycle arrest and ultimately cell death (apoptosis).4
About Boehringer Ingelheim in Oncology
Building on scientific expertise and research excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.
The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition.
Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to advance the disease area.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
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Footnotes
*Afatinib, nintedanib and volasertib are investigational compounds and are not yet approved. Their safety and efficacy have not yet been fully established.
Referências
- Hilberg, F et al. BIBF1120: Triple angiokinase inhibitor with sustained receptor blockade and good anti-tumor efficacy. Cancer Research 2008;68(12): 4774-4782.
- Folkman, N. Clinical Applications of Research on Angiogenesis. New England Journal of Medicine 1995;333: 1757-1763.
- Ellis, L et al. VEGF-targeted therapy: mechanisms of anti-tumour activity. Nature Reviews Cancer 2008;8: 579-591.
- Schöffski, P. Polo-Like Kinase (PLK) Inhibitors in Preclinical and Early Clinical Development in Oncology. Oncologist 2009;14(6):559-570.