Results of the clinical study CALYPSO Published in The Journal of Clinical Oncology

Merck Sharp & Dohme Corp.Results of the clinical study CALYPSO, published online by The Journal of Clinical Oncology, show that patients in this study with platinum-sensitive relapsed ovarian cancer experienced longer progression-free survival than patients taking the current standard of care. CALYPSO is the largest international, multicentre Phase III study of patients with platinum-sensitive relapsed ovarian cancer.

This study showed the combination of CAELYX® (pegylated liposomal doxorubicin) and carboplatin extended progression-free survival, which was the primary endpoint, when compared to the current standard combination therapy, carboplatin and paclitaxel. The study demonstrated a median progression-free survival of 9.4 months in the carboplatin and paclitaxel control group and 11.3 months in the carboplatin and PLD study group [HR 0.821 (95% CI 0.72, 0.94); P=.005]. In addition, the control group had higher incidences of peripheral neuropathy (28% vs. 5%), hypersensitivity reactions (19% vs. 5%) and alopecia (84% vs. 7%) than those in the study group.

"We are encouraged by the results of the study," said Eric Pujade-Lauraine, MD, PhD, professor, Université de Paris Descartes, France and head of Group d’Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO). "This data's impact has resulted in the CAELYX/Carboplatin combination being included in important guidelines, such as NCCN and AGO for women with recurrent ovarian cancer."

In 75 percent of patients, ovarian cancer is diagnosed at an advanced stage. Relapse is inevitable for most and a majority of these relapses occur more than 6 months after the end of the last platinum-based chemotherapy course, potentially allowing the disease to be sensitive to a rechallenge with a platinum-based treatment.

The lower incidences of peripheral neuropathy and hypersensitivity reactions observed in the carboplatin and study group are important because these side effects can sometimes be dose-limiting and may lead to treatment discontinuation.

"Often, side effects such as loss of sensation in the fingers and toes, and hair loss diminish patients' quality of life and self-image, so we were encouraged to see lower incidences of these side effects in the CAELYX® and carboplatin combination," said Eric Rubin, vice president of Merck Research Laboratories . "Improvements in progression-free survival that resulted from use of CAELYX with carboplatin is helpful information for health care professionals when treating patients with platinum-sensitive relapsed ovarian cancer."

About The Journal of Clinical Oncology paper
Title: Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin for Patients with Platinum-Sensitive Ovarian Cancer in Late Relapse

About CALYPSO
Patients with histologically-proven ovarian cancer who relapsed more than 6 months after first or second-line platinum and taxane-based therapies were randomized by stratified blocks to the carboplatin (C) and pegylated liposomal doxorubicin (PLD) (CD) group or carboplatin and paclitaxel (P) (CP) group. Patients received carboplatin AUC 5 plus PLD 30mg/m2 every 4 weeks or carboplatin AUC 5 plus paclitaxel 175mg/m2 every 3 weeks for at least 6 cycles. The primary endpoint for the CALYPSO study was progression-free survival (PFS); secondary endpoints were toxicity, quality of life, and overall survival.

Overall, 976 patients were recruited. With median follow-up of 22 months, PFS for the CD arm was statistically superior to the CP arm [HR 0.821 (95% CI 0.72, 0.94); P=.005]; median PFS was 11.3 months versus 9.4 months, respectively. A total of 334 deaths have occurred. Overall severe non-hematologic toxicity (37% vs 28%; P<.01) leading to early discontinuation (15% vs 6%; P<.001) occurred more frequently in the CP arm. More frequent Grade 2 or greater alopecia (84% vs 7%), hypersensitivity reactions (19% vs 5%), and sensory neuropathy (28% vs 5%) were observed in the CP arm; more hand-foot syndrome (grade 2-3: 13% vs 2%), nausea/vomiting (35% vs 24%), and mucositis (15% vs 7%) were observed in the CD arm.

About CAELYX
CAELYX is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride, a widely used cytotoxic agent.

CAELYX is approved in the European Union (EU) as monotherapy for metastatic breast cancer in patients who are increased cardiac risk. CAELYX is also approved in the EU for the treatment of advanced ovarian cancer in women who have failed first-line, platinum-based therapy and for the treatment of AIDS-related Kaposi's sarcoma in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease) and in combination with Velcade (bortezomib) for Injection for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

MSD has exclusive ex-U.S. marketing rights to CAELYX, except in Japan and Israel, through a distribution agreement with ALZA, a wholly owned subsidiary of Johnson & Johnson of New Brunswick, N.J., USA. The product is marketed in the United States under the trade name DOXIL® by Ortho Biotech Products, L.P. Full prescribing information for CAELYX can be found at www.ema.europa.eu/humandocs/Humans/EPAR/caelyx/caelyx.htm

About MSD
Today's MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching programs that donate and deliver our products to the people who need them. MSD. Be Well. For more information, visit www.merck.com.

About GINECO and GCIG
GINECO is a cooperative group of clinicians dedicated to gynecological cancer research in France and to high quality information for health professionals through the website www.Infocancer.org. GINECO is one of the 18 members of the GCIG (Gynecology Cancer Inter-Group) an international organization aimed to promote clinical trial collaboration.

The GINECO group is a non-profit independent research organization, with an integrated and multidisciplinary approach to cancer research fully dedicated to:

  • Promoting top level clinical research
  • Supporting and coordinating researchers’ actions
  • Encouraging multidisciplinary partnerships
  • Contributing to defining a national policy to fight cancer
  • Improving public knowledge about the disease and provide information, that covers all the main aspects of oncology

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