ASCO abstracts highlight late-stage Sanofi Oncology pipeline

Sanofi (EURONEXT: SAN and NYSE: SNY) announced today abstracts spanning the company’s innovative marketed and late-stage development compounds will be featured at the 2012 American Society of Clinical Oncology Annual Meeting in Chicago, Ill., June 1-5. Sanofi products are noted in more than 170 abstracts to be presented at the meeting.

This year’s meeting theme – Collaborating to Conquer Cancer – aligns with Sanofi Oncology’s approach to drug discovery and development through external partnerships that complement internal expertise. Diverse collaborations with leading scientists, academic institutions and other industry partners have brought forth numerous compounds to be highlighted in poster and oral presentations at the meeting, including investigational agents Zaltrap™ (aflibercept) and the JAK2 inhibitor, SAR302503.

“The data to be presented at ASCO underscore the commitment of Sanofi Oncology to the patient and focus on innovative scientific discovery to develop cancer therapies that meet patient needs,” said Debasish Roychowdhury, M.D., Senior Vice President and Head, Sanofi Oncology. “I thank the investigators and our partners for their strong collaboration in helping realize this progress.”

Zaltrap™ (aflibercept)

Zaltrap™ is a novel investigational recombinant human fusion protein that binds VEGF-A, VEGF-B and PlGF. A Biologics License Application (BLA) for Zaltrap for use in combination with irinotecanfluoropyrimidine- based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen is under review at the U.S. Food and Drug Administration (FDA). A marketing authorization application for Zaltrap for the same indication is also under review at the European Medicines Agency (EMA). Abstracts to be presented at ASCO include:

• Effects of prior bevacizumab use on outcomes from the VELOUR study: a Phase III study of aflibercept and FOLFIRI in patients with metastatic colorectal cancer after failure of an oxaliplatin regimen.
  – Presenter: Carmen Allegra M.D., University of Florida Shands Cancer Center, USA
  – Oral presentation #3505; Sunday, June 3, 11:15 am CT, E Hall D1
• A randomized Phase II trial of weekly topotecan with and without AVE0005 (aflibercept) in patients with platinum-treated extensive stage small cell lung cancer
  – Presenter: Jeffrey W. Allen, M.D., University of Tennessee Cancer Institute, USA
  – Oral Presentation #7005; Monday, June 4, 9:30 am CT, E Hall D2
• Aflibercept versus placebo in combination with FOLFIRI in previously treated metastatic colorectal cancer: Mean overall survival estimation from a Phase III trial
  – Presenter: Florence Joulain, MSc, Sanofi, France
  – Poster Presentation #3602; Monday, June 4, 8:00 am – 12:00 pm CT, S Hall A2, Poster Board #34G

Jevtana® (cabazitaxel)

Jevtana®, a novel, semisynthetic second-generation taxane, has been approved by the FDA, the EMA and other national health authorities in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer who were previously treated with a docetaxel-containing treatment regimen. Abstracts accepted for presentation at ASCO include:

• Prostate-specific antigen decline is not a surrogate for overall survival in patients with metastatic castrate-resistant prostate cancer who failed first line chemotherapy
  – Presenter: Susan Halabi, Ph.D., Duke University, USA
  – Oral Presentation #4515, Saturday June 2, 11:30 am CT, E Arie Crown Theater
• Firstana Study: First-line use of cabazitaxel in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: A three-arm study in comparison with docetaxel – Presenter: Stephane Oudard, M.D., Ph.D., Descartes University, France
  – TPS4696, Sunday June 3, 8:00am – 12:00pm CT, S Hall A2, Poster Board 16G
• Proselica study: Comparison of two doses of cabazitaxel + prednisone in patients with metastatic castration-resistant prostate cancer previously treated with a docetaxelcontaining regimen
  – Presenter: Mario Eisenberger, M.D., Johns Hopkins Medical Institutions, USA
  – TPS4692, Sunday June 3, 8:00am – 12:00 pm CT, S Hall A2, Poster Board #16B
• Phase II trial of cabazitaxel in patients with advanced or metastatic transitional cell carcinoma of the urothelial tract who have progressed within less than 12 months after cisplatin-based chemotherapy: A Spanish Oncology Genitourinary Group (SOGUG) study
  – Presenter: Jose Angel Arranz Arija, M.D., Hospital General Universitario Gregorio Maranon, Spain
  – TPS4672, Sunday June 3, 8:00am – 12:00pm CT, S Hall A2, Poster Board #13G

SAR302503 (JAK2 inhibitor) and ombrabulin

The Sanofi Oncology pipeline portfolio has more than 15 investigational compounds in clinical development, including small molecules and biological agents. Selected abstracts to be presented at ASCO include:

• JAKARTA: A phase III, multicenter, randomized, double-blind, placebo-controlled, three-arm study of SAR302503 in patients with intermediate-2 or high-risk primary myelofibrosis, postpolycythemia vera MF, or post-essential thrombocythemia MF with splenomegaly
  – Presenter: Aminesh Pardanani, MBBS, Ph.D., Mayo Clinic, USA
  – TPS6639; Monday June 4, 1:15pm – 5:15pm CT, S Hall A2, Poster Board #30C
• A randomized phase II, open-label trial of orally administered SAR302503 in patients with polycythemia vera or essential thrombocythemia who are resistant or intolerant to hydroxyurea
  – Presenter: Ayalew Tefferi, M.D., Mayo Clinic, USA
  – TPS6641, Monday, June 4, 1:15pm – 5:15pm CT, S Hall A2, Poster Board #31B
• OPSALIN: A phase II placebo-controlled randomized study of ombrabulin in patients with platinum-sensitive recurrent ovarian cancer treated with carboplatin and paclitaxel
  – Presenter: Eric Pujade-Lauraine, M.D., Ph.D., Hopital Hotel-Dieu, France
  – TPS5112 , Sunday, June 3, 8:00am – 12:00 pm CT S Hall A2, Poster Board #30A
• A phase I study of ombrabulin combined with bevacizumab in patients with advanced solid tumors
  – Presenter: Gianluca Del Conte, MD, Fondazione IRCCS Istituto Nazionale dei Tumori,Italy
  – Poster Presentation #3080, Monday June 4, 8:00am – 12:00pm CT, S Hall A2, Poster Board #17F

About Zaltrap™ (aflibercept) and the Clinical Development Program

Zaltrap™ (aflibercept), also known in the scientific literature as VEGF Trap, is an investigational angiogenesis inhibitor with a unique mechanism of action. This fusion protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. Zaltrap is being jointly developed under a global collaboration agreement between Sanofi Oncology and Regeneron Pharmaceuticals, Inc.

About Jevtana® (cabazitaxel)

Jevtana® (cabazitaxel) is a taxane chemotherapy approved in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing treatment regimen.

About SAR302503 (JAK2 Inhibitor)

JAK2 is a key enzyme for blood cell development. SAR302503 is a novel, investigational, selective JAK2 inhibitor that has shown activity in preclinical studies against two activating mutations (JAK2V617F and MPLW515L) of JAK2. Dysregulated JAK2 signaling is thought to be a cause of MF and related disorders. SAR302503 is being investigated in multiple hematologic and solid tumor types.

About ombrabulin

Ombrabulin is an investigational small-molecule vascular-disrupting agent currently in Phase III clinical trials in patients with advanced soft tissue sarcoma, a disease with high unmet medical need, who have not responded to prior treatments and in phase II trials in NSCLC & ovarian cancer. In 2011, ombrabulin was granted orphan drug status for soft tissue sarcoma by the FDA because it is intended to treat a disease in a small patient population.