Clovis Oncology Announces Data Presentations at 16th World Conference on Lung Cancer

Four rociletinib mini-oral presentations and two scientific posters debuting at World Conference on Lung Cancer in Denver

BOULDER, Colo.--()--Clovis Oncology (NASDAQ:CLVS) today announced that rociletinib, the company’s oral targeted covalent (irreversible) mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of EGFR-mutated, T790M positive non-small cell lung cancer (NSCLC), is the subject of four mini-oral presentations and two poster sessions at the 16th World Conference on Lung Cancer. Hosted by the International Association for the Study of Lung Cancer (IASLC), the conference will take place September 6-9, 2015 in Denver.

“We look forward to sharing updated data from the pivotal TIGER-X trial, analyzing the clinical activity of rociletinib in multiple subsets of patients with advanced EGFR mutant NSCLC, specifically in those with a history of CNS metastases, as well as in patients with T790M negative disease,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “The coming months are shaping up to be a very busy and important time for rociletinib, as we move forward with our pivotal TIGER clinical trial program and prepare for potential product launches in both the United States and Europe.”

Mini-Oral Presentations

Rociletinib in NSCLC patients with negative central testing for T790M in TIGER-X (Abstract #951/MINI03.10)

  • Heather Wakelee, MD, Stanford University Medical Center
  • Monday, Sept. 7, 4:45-6:15pm MT
  • Location: Four Seasons Ballroom F1 + F2

Identification of effective drug combinations to prevent or delay resistance to the EGFR mutant selective inhibitor rociletinib (CO-1686) (Abstract #3010/MINI09.04)

  • Andrew D. Simmons, PhD, Clovis Oncology
  • Monday, Sept. 7, 4:45-6:15pm MT
  • Location: Rooms 205 + 207

Dose optimization of rociletinib for EGFR mutated NSCLC (Abstract #967/MINI16.03)

  • Jonathan W. Goldman, MD, UCLA Health
  • Tuesday, Sept. 8, 4:45-6:15pm MT
  • Location: Four Seasons Ballroom F3 + F4

Activity of rociletinib in EGFR mutant NSCLC patients with a history of CNS involvement (Abstract #965/MINI16.04)

  • D. Ross Camidge, MD, PhD, University of Colorado Denver
  • Tuesday, Sept. 8, 4:45-6:15pm MT
  • Location: Four Seasons Ballroom F3 + F4

Poster Sessions

Poster P1.01-076 – TIGER-1: A randomized, open-label, phase 2/3 study of rociletinib (CO-1686) or erlotinib as first-line treatment for EGFR-mutant non-small cell lung cancer

  • D. Ross Camidge, MD, PhD, University of Colorado Denver
  • Monday, Sept. 7, 9:30am-4:45pm MT
  • Location: Exhibit Hall

Poster P1.01-086 – TIGER-3: A phase 3, open-label, randomized study of rociletinib versus cytotoxic chemotherapy in patients with mutant EGFR non-small cell lung cancer progressing on prior EGFR tyrosine kinase inhibitor therapy and doublet chemotherapy

  • James Chih-Hsin Yang, National Taiwan University Hospital
  • Monday, Sept. 7, 9:30am-4:45pm MT
  • Location: Exhibit Hall

About Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or “normal” EGFR at anticipated therapeutic doses. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates, the corresponding development pathways of our companion diagnostics, actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions regarding drug labeling, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics, including competitive developments. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

Contacts

Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com

Release Summary

Clovis Oncology Announces Data Presentations at 16th World Conference on Lung Cancer

Contacts

Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com