Poniard's Phase 2 Trial Confirms Survival Benefit In Small Cell Lung Cancer
Small Cell Lung Cancer
Picoplatin results confirm data analysis from the Company's Phase 2 clinical trial, which demonstrated a survival benefit in patients with recurrent small cell lung cancer (SCLC).
In the updated analysis, efficacy results from 77 evaluable patients showed a median overall survival of 27 weeks with picoplatin. This compares with a median survival of approximately 17 to 22 weeks for patients who receive other second-line chemotherapy according to the 2007 National Comprehensive Cancer Network practice guidelines. Picoplatin is currently being evaluated in a pivotal Phase 3 trial in SCLC, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPEAR (Study of Picoplatin Efficacy After Relapse) trial is enrolling patients who are refractory to, or who have progressed within six months of completing, treatment with first-line platinum-containing chemotherapy (cisplatin or carboplatin).
"Picoplatin extended survival in patients with recurrent small cell lung cancer in this clinical trial and has the potential to be a safe and efficacious adjunct or alternative to topotecan, the only agent approved for this indication," said John R. Eckardt, M.D., a clinical trial investigator and medical oncologist at The Center for Cancer Care and Research in St. Louis. "New treatments are urgently needed for platinum-resistant and -- refractory SCLC patients because they often experience rapid disease progression and low overall survival following treatment with currently available drugs, which have significant toxicities."
"The overall survival data from our Phase 2 trial supports our expectation that picoplatin therapy should demonstrate a greater than 50 percent increase in survival compared to best supportive care in our ongoing Phase 3 pivotal trial," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "The picoplatin data generated to date provide a strong rationale to bring this new agent to market to treat SCLC patients who have failed treatment with previous platinum-based therapy. In addition, the injection of picoplatin once every three weeks is a convenient regimen resulting in manageable myelosuppression and no treatment-related deaths. This safety profile supports additional studies combining picoplatin with other agents in a first and second-line setting."
The new picoplatin Phase 2 data were presented today during a poster session at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) at McCormick Place in Chicago.
The open-label, multi-center Phase 2 trial was designed to confirm the clinical activity of picoplatin as second-line therapy in patients with platinum-refractory disease or platinum-resistant or platinum-sensitive disease who had progressed within six months after receiving first-line treatment with a platinum-based chemotherapy, such as cisplatin or carboplatin. Efficacy endpoints included response rates, progression-free survival, overall survival, improvement in disease-related symptoms and disease control (defined as complete response, partial response and stable disease). The trial was conducted at clinical sites in North America and Eastern Europe.
In addition to the median overall survival of 27 weeks, results showed that the disease control rate was 48 percent in the 77 evaluable patients. This is similar to that observed with currently available treatments. At the time of the analysis, there had been 54 deaths from disease progression among the 77 patients. The most common side effects were hematologic and included thrombocytopenia, anemia and neutropenia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths occurred.
SCLC is the most aggressive and deadly form of lung cancer and accounts for approximately 20 percent of all lung cancer cases. The current two-year survival rate for patients with extensive SCLC is less than 10 percent with current management options. The estimated incidence of lung cancer in the United States in 2006 was 174,500, according to the National Cancer Institute. The estimated incidence in Europe in 2006 was 386,300, according to the International Agency for Research on Cancer.
SCLC is currently treated with platinum therapies, but many patients do not respond, and if they do respond, they typically relapse within a short time after treatment. There is currently no FDA-approved therapy and no consistent and effective therapy for SCLC patients who have platinum-resistant or -refractory disease after treatment failure with first-line combination therapy with either cisplatin or carboplatin. No new drugs have been approved by the FDA for the treatment of platinum-resistant or -refractory SCLC in nearly a decade.