Overall Response Rate of 66 Percent Observed in Pembrolizumab-treated Patients Whose Cancer Progressed on Brentuximab Vedotin
Phase 2 Study Planned for the First Half of 2015 (KEYNOTE-087)
KIRKLAND, QC, Dec. 6, 2014 /CNW Telbec/ - Merck, known as MSD outside of Canada and the United States, announced today early study findings demonstrating that patients treated with pembrolizumab, the company's investigational anti-PD-1 cancer therapy, achieved an overall response rate of 66 percent, as assessed by International Harmonization Project response criteria (n=19/29: 95% CI, 46-82). The study was conducted in transplant-ineligible and failure patients with relapsed/refractory classical Hodgkin Lymphoma (cHL) whose disease had progressed on or after treatment with brentuximab vedotin.
Complete remission was achieved in 21 percent of patients (n=6/29) in the study. At the time of analysis, 89 percent of responses were ongoing (n=17/19) with the median duration of response not yet reached (range 1+ to 185+ days).
These early findings, from the ongoing Phase 1b KEYNOTE-013 study, were described for the first time as part of the official press program at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco (ABSTRACT #290) and will be presented in an oral session on December 8 by Dr. Craig Moskowitz, Memorial Sloan Kettering Cancer Center.
"These early data presented at ASH 2014 are very promising and show response rates of 66 percent with pembrolizumab in patients with classical Hodgkin Lymphoma," said Dr. Craig Moskowitz, clinical director, Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center. "There are few options for patients with multiple relapsed or refractory, classical Hodgkin Lymphoma, and pembrolizumab should continue to be studied for the treatment of this cancer."
"Merck's immuno-oncology development program spans more than 30 different types of cancer including a focus on blood cancers like classical Hodgkin Lymphoma," said Dr. Alise Reicin, vice president, Global Clinical Development, Oncology, Merck Research Laboratories. "Response rates being observed with pembrolizumab in these patients support the potential role of the PD-1 pathway in blood cancers. We look forward to initiating additional studies including a Phase 2 trial in classical Hodgkin Lymphoma in the first half of 2015."
Early Findings for Investigational Use of Pembrolizumab in Relapsed/Refractory cHL
Data from a cohort of the ongoing Phase 1b KEYNOTE-013 study evaluated pembrolizumab monotherapy at 10 mg/kg every two weeks in patients with relapsed/refractory classical Hodgkin Lymphoma who had progressed on or after treatment with brentuximab vedotin after failure of autologous stem-cell transplant, or who were transplant-ineligible (n=29).
Antitumor Activity by International Harmonization Project Response Criteria*
| Transplant n=9 (%) |
Transplant n=20 (%) |
Total n=29 (%) |
|
| Overall Response Rate |
4 (44) |
15 (75) |
19 (66) |
| Complete Remission |
2 (22) |
4 (20) |
6 (21) |
| Partial Remission |
2 (22) |
11 (55) |
13 (45) |
| Stable Disease |
3 (33) |
3 (15) |
6 (21) |
| Clinical Benefit Rate |
7 (78) |
18 (90) |
25 (86) |
| Progressive Disease |
2 (22) |
2 (10) |
4 (14) |
*Analysis cut-off date: November 17, 2014
Median time to response was 12 weeks. In the transplant ineligible/refusal patient group, eight patients were ineligible and one patient refused transplant, respectively. The patient who refused transplant achieved a complete remission.
Adverse events were consistent with previously reported safety data for pembrolizumab. The most common treatment-related adverse events (occurring in greater than or equal to two patients) included hypothyroidism (n=3), pneumonitis (n=3), constipation (n=2), diarrhea (n=2), nausea (n=2), hypercholesterolemia (n=2), hypertriglyceridemia (n=2) and hematuria (n=2). Sixteen patients (55%) experienced at least one treatment-related adverse event of any grade. Grade 3 treatment-related adverse events occurred in a total of three patients and included axillary pain, hypoxia, joint swelling, and pneumonitis. No Grade 4 treatment-related adverse events or treatment-related deaths were reported.
About the KEYNOTE-013 Study
KEYNOTE-013 is an ongoing multi-center, non-randomized Phase 1b trial of approximately 106 patients evaluating the safety, tolerability, and efficacy of pembrolizumab monotherapy in patients with blood cancers, including myelodysplastic syndromes, multiple myeloma, Hodgkin lymphoma, mediastinal large B cell lymphoma and non-Hodgkin's lymphoma. The primary endpoints of the study include overall safety, tolerability, and complete remission rate (as measured by International Harmonization Project Response Criteria); secondary endpoints include overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and duration of response.
About Pembrolizumab
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
About Lymphoma
Lymphoma is a type of blood cancer that affects the lymphatic system, which removes excess fluids from the body and produces immune cells. Abnormal lymphocytes, a type of white blood cell that fight infection, become lymphoma cells, which multiply and collect in the lymph nodes and other tissues. Over time, these cancerous cells impair the immune system.1 Hodgkin lymphoma is different from other lymphomas because it contains Reed-Sternberg cells, a specific type of large cancer cells.2
In 2012, more than 450,000 people worldwide were estimated to have been diagnosed with lymphoma (Hodgkin lymphoma and non-Hodgkin lymphoma); more than 225,000 people died from the condition.3
In Canada, it is estimated that in 2014, 990 Canadians will be diagnosed with Hodgkin lymphoma. Actual mortality data for 2010 indicates that 126 Canadians died from Hodgkin lymphoma.4
Our Focus on Cancer
Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. For Merck Oncology, helping people fight cancer is our passion, supporting accessibility to our cancer medicines is our commitment, and pursuing research in immuno-oncology is our focus to potentially bring new hope to people with cancer.
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside Canada and the United States. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health 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 policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2013 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
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1 American Society of Hematology. Blood Cancers. Available at: http://www.hematology.org/Patients/Cancers/. Accessibility verified on November 3, 2014.
2 MD Anderson Cancer Center. Hodgkin's Lymphoma. Available at: http://www.mdanderson.org/patient-and-cancer-information/cancer-information/cancer-types/hodgkins-lymphoma/index.html. Accessibility verified on December 4, 2014.
3 GLOBOCAN. World. Available at: http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessibility verified on November 3, 2014.
4 Canadian Cancer Society. Hodgkin lymphoma cancer statistics. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/hodgkin-lymphoma/statistics/?region=on#ixzz3KyAPfFDd.4 . Accessibility verified on December 4, 2014.
SOURCE: Merck
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