Bavituximab Trials PDF Print E-mail

Phase III Trial: SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study)

Status: Recruiting

Focus: Second-Line (Stage IIIb or IV) Lung Cancer

SUNRISE is a pivotal Phase III randomized, controlled, double-blind, multinational clinical trial evaluating the efficacy and safety of bavituximab, a novel immunotherapy plus docetaxel versus placebo plus docetaxel as a second-line treatment for patients with Stage IIIb/IV non-squamous non-small cell lung cancer (NSCLC). The trial is expected to enroll up to 600 evaluable patients at more than 100 leading worldwide sites including in the U.S. and Western Europe.

The SUNRISE trial is currently open for enrollment and patients will be randomized one to one to receive bavituximab 3 mg/kg or placebo administered as a weekly infusion for up to six 21-day cycles plus commercially-available docetaxel 75 mg/m2 that will be administered IV on Day 1 of each 21-day treatment cycle (up to 6 cycles) in accordance with the prescribing information.

In a Phase II trial, in patients who mirror the entry criteria for the SUNRISE trial, data from a randomized, double-blind, placebo-controlled Phase II trial showed an improvement in median overall survival (OS) of 11.7 months in the 3 mg/kg bavituximab plus docetaxel arm compared to 7.3 months in the combined control arm, with a persistent separation in the Kaplan Meier survival curves (HR=0.662). In addition, subgroup analyses of overall survival by key patient characteristics favored the bavituximab 3 mg/kg arm, including age, gender, ECOG status, ethnicity and prior treatment. The results also indicated that the 3 mg/kg bavituximab plus docetaxel combination was well-tolerated with no significant differences in adverse events between the trial arms. Results from the trial also showed that overall response rate (ORR) and progression free survival (PFS) both favored the 3 mg/kg bavituximab plus docetaxel arm. Specifically, data showed an ORR of 17.1% months in the 3 mg/kg bavituximab plus docetaxel arm versus 11.3% in the combined control arm and PFS of 4.2 months in the 3 mg/kg bavituximab plus docetaxel arm, versus 3.9 months in the combined control arm. These results were presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Lung cancer is the leading cause of cancer deaths worldwide. The major types of lung cancer are small-cell lung cancer and non-small cell lung cancer. According to the American Cancer Society, about 85% of lung cancers are non-small cell lung cancers. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of non-small cell lung cancer. The Society predicts that in 2013 about 228,190 new cases of lung cancer were diagnosed.

Bavituximab has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of second-line non-small cell lung cancer (NSCLC).

For more information on the SUNRISE trial, please visit www.sunrisetrial.com .

The unique identifier for this trial on ClinicalTrials.gov is NCT01999673 .


Phase I/II Trial: IST of bavituximab in combination with sorafenib in patients with liver cancer

Status : Recruiting

Focus: Advanced Hepatocellular Carcinoma (liver cancer)

This is a Phase I/II non-randomized, open-label trial of approximately 50 patients with advanced hepatocellular carcinoma. Patients will receive bavituximab weekly and sorafenib (400 mg) twice daily, until disease progression or toxicity. Phase I of the trial is dose escalation (0.3, 1 or 3 mg/kg) to determine the maximu m tolerated dose (MTD) and Phase II is expansion of the study at the MTD.

Primary objectives are to determine the MTD of bavituximab in patients with advanced HCC treated with sorafenib and the radiographic median time to progression. Secondary objectives include response rate, progression free-survival, overall survival, safety and tolerability. The study includes biopsy collection for evaluating changes in immune response following bavituximab treatment.

Data from the trial has been accepted for oral presentation at the Society of Surgical Oncology Cancer Symposium on March 13, 2014.

Liver is the fifth most prevalent cancer worldwide and the most common of which hepatocellular carcinoma, which begins in the main type of liver cell (hepatocyte). This cancer forms in the tissues of the liver and can spread to other parts of the body. According to the National Cancer Institute, more than 30,000 new cases were diagnosed in the United States in 2013.

The unique identifier for this trial on ClinicalTrials.gov is

Phase Ib Study: IST of bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC

Status: Closed to Enrollment

Focus: Advanced and Untreated Stage IV NSCLC

This is a Phase Ib single-arm, open-label trial of up to 25 patients with previously untreated locally advanced or metastatic non-squamous NSCLC will receive up to six 21-day cycles of the drugs pemetrexed and carboplatin with weekly bavituximab until progression or toxicity. The primary endpoint of the study is to determine the safety, dose-limiting toxicity (DLT) and recommended Phase II dose of bavituximab in combination with carboplatin and pemetrexed in advanced non-squamous NSCLC. Secondary endpoints include assessment of overall response rate (ORR) measured by RECIST criteria, progression-free survival (PFS) and overall survival (OS) and exploratory biomarkers.

Lung cancer is the leading cause of cancer deaths worldwide. The major types of lung cancer are small-cell lung cancer and non-small cell lung cancer. According to the American Cancer Society, about 85% of lung cancers are non-small cell lung cancers. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of non-small cell lung cancer. The Society predicts that in 2013 about 228,190 new cases of lung cancer were diagnosed.

The unique identifier for this trial on ClinicalTrials.gov is NCT01323062

Phase I Study: IST of bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer

Status: Closed to Enrollment

Focus: HER2-negative Metastatic Breast Cancer

This is a Phase I single-arm, open-label trial of 14 patients with HER2-negative metastatic breast cancer were enrolled. Patients were treated with paclitaxel (80 mg/m2) weekly for three weeks out of each four-week cycle and bavituximab (3 mg/kg) weekly. The primary endpoint is to determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. Patients will also be assessed for overall response rate and median progression free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Interim data from this Phase I trial showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria.

Breast cancer is the uncontrolled growth of cancerous cells that originate in breast tissue. In advanced breast cancer, the cancer has spread (metastasized) to other parts of the body. There are many forms of breast cancer based in part on genetic characteristics, such as human epidermal growth factor receptor-2 (HER2)-positive and HER2-negative. Three in four women have HER2-negative breast cancer, which does not spread as quickly as HER2-positive disease, but remains an aggressive cancer with some having a more difficult-to-treat form known as "triple-negative," which means they test negative for three main receptors - HER2, estrogen receptor [ER] and progesterone receptor [PR].

The unique identifier for this trial on ClinicalTrials.gov is NCT01288261

Phase I Study: IST of bavituximab in combination with capecitabine and radiation therapy in patients with advanced rectal cancer

Status: Recruiting

Focus: Stage II or III Rectal Adenocarcinoma

This is a Phase I single-arm, open-label, dose-escalation trial will enroll up to 18 patients with stage II or III rectal adenocarcinoma, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients will receive weekly bavituximab for a total of 8 weeks with administration of capecitabine (825 mg/m2) on each of the 28 days of radiation therapy (1.8 Gy/fraction) over 6 weeks, followed by 2 weeks of bavituximab administration by itself. Surgery will follow the last bavituximab administration by 4-8 weeks (i.e., 6-10 weeks following completion of radiation therapy). The primary endpoint is to determine the safety, feasibility and tolerability of combining bavituximab with a standard platform of capecitabine and radiation therapy. Secondary endpoints include the assessment of any anti-tumor activity by objective response as determined by MR imaging and histopathological response in patients.

Rectal cancer occurs on the last eight to 10 inches of the colon. They are often referred to together as colorectal cancers, and are the second leading cause of cancer-related deaths in the United States.

The unique identifier for this trial on ClinicalTrials.gov is NCT01634685

Phase Ib Study: IST of bavituximab and ipilimumab in patients with advanced melanoma

Status: Recruiting

This is an open label, two-arm, randomized, two agent, single-center Phase Ib trial of bavituximab plus ipilimumab in up to 16 patients with advanced melanoma. Patients will be randomized 2:1 to have a 2 week lead-in treatment with bavituximab (3mg/kg IV over 90 minutes) followed by combination therapy of ipilimumab (3mg/kg IV over 90 minutes every 3 weeks x 4) + bavituximab (3mg/kg IV over 90 minutes every 3 weeks x 12) versus ipilimumab alone (3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3).

Preclinical data in models of melanoma showed that phosphatidylserine (PS)-targeting antibodies reactivate tumor immunity at multiple levels and when combined with an anti-CTLA-4 antibody, an FDA-approved immunotherapy, yielded enhanced anti-tumor activity when compared to either antibody alone with no additional toxicity following multiple treatment doses.

Melanoma is a form of cancer that begins in melanocytes which are most commonly located in the basal layer of the epidermis, but can also be found in the eyes, respiratory tract, gastrointestinal tract, and the mucous membranes of the genitalia and mouth. Most occur in the skin, but they may occur at any site to which melanocytes have migrated. According to the National Cancer Institute, more than 76,000 new cases were diagnosed in the United States in 2013.

The unique identifier for this trial on ClinicalTrials.gov is NCT01999673

Citations to above market statements are available upon request.