Avastin Meets Primary Endpoint in a Second Phase III Study in Ovarian Cancer

Genentech announced that a second large, Phase III, international study showed that the combination of Avastin (bevacizumab) and chemotherapy, followed by the continued use of Avastin alone, increased PFS, compared to chemotherapy alone. Adverse events were consistent with those observed in pivotal trials of Avastin across tumor types for approved indications. Data from the study, ICON7, will be submitted for presentation at an upcoming medical meeting.

The ICON7 study sponsored by the Medical Research Council (MRC) and conducted by an international network of researchers in the Gynecologic Cancer Inter Group (GCIG) enrolled 1,528 women with newly diagnosed ovarian cancer who had already undergone surgery. Another Phase III study of Avastin (GOG 0218) in women with previously untreated advanced ovarian cancer presented in June at the Annual Meeting of the American Society of Clinical Oncology (ASCO) also met its primary endpoint of PFS. The GOG 0218 study used an Avastin dose of 15mg/kg (every three weeks) in combination with carboplatin and paclitaxel, followed by the continued use of Avastin alone, for a total duration of up to 15 months. In ICON7, majority of patients had advanced stage ovarian cancer; however, the trial also included patients with early stage disease. The ICON7 study used an Avastin dose of 7.5mg/kg (every three weeks) in combination with the same chemotherapy regimen, followed by the continued use of Avastin alone, for a total duration of up to 12 months.

Source: Genentech

Afinitor More than Doubles PFS in Advanced Pancreatic NET

Novartis announced the results of a Phase III study, which showed that Afinitor (everolimus) tablets plus best supportive care (BSC) more than doubled PFS, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). Pancreatic NET can grow aggressively and at the time of diagnosis, nearly 60% of all patients have advanced disease, meaning the cancer has spread to other parts of the body and has become more difficult to treat. The median OS for patients with advanced pancreatic NET is 24 months. Currently, surgery and chemotherapy are the only available treatment options for patients with advanced pancreatic NET.

Findings from the RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) study demonstrated that everolimus extended the PFS from 4.6 months to 11.0 months when compared with placebo. Additionally, the data showed everolimus reduced the risk of cancer progression by 65%. The study was presented at the 12^th World Congress on Gastrointestinal Cancer, and is part of the largest clinical trial program in patients with advanced NET. Worldwide regulatory filings are planned for everolimus as the first mTOR inhibitor treatment for patients with advanced pancreatic NET. Afinitor is approved for the treatment of patients with advanced renal cell carcinoma (RCC), whose disease has progressed on or after treatment with the vascular endothelial growth factor (VEGF)-targeted therapy.

Source: Novartis

Eisai Announces Results of Phase III Study of Dacogen in AML

Eisai announced preliminary results from a randomized Phase III clinical trial of Dacogen (decitabine) for injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML).

OS was the primary endpoint of this study. Although Dacogen did not reach statistically significant superiority over the control arm, a trend was evident. The most frequently reported adverse events included neutropenia, anemia, thrombocytopenia, fever, and pneumonia. Sepsis and febrile neutropenia were reported as serious adverse events. Eisai is further examining the data to better understand the full implications of the study. Based on the primary analysis and supporting secondary data from additional endpoints, Eisai plans to submit a supplemental new drug application (sNDA) to the FDA for Dacogen for the treatment of elderly patients with AML and poor- or intermediate-risk cytogenetics. The submission of an application is planned by March 31, 2011. Recently, a five-day dosing regimen for Dacogen was approved by the FDA for the treatment of MDS (Myelodysplastic syndromes).

Source: Eisai

GDC-0449 does not Meet Primary Endpoint in 1^st Line mCRC

Curis announced top line results from a Phase II clinical trial conducted by Roche and Genentech of GDC-0449, a first-in-class Hedgehog pathway inhibitor. The Hedgehog pathway is normally active during embryonic development and plays a central role in cell differentiation and proliferation. Inappropriate activation or dysregulation of the Hedgehog pathway is believed to play a critical role in the proliferation and survival of certain cancer cells, including in basal cell carcinoma and medulloblastoma, as well as in colorectal, ovarian, pancreatic, small cell lung, and breast cancers.

GDC-0449 was tested in combination with Avastin and FOLFOX or FOLFIRI chemotherapy in first-line metastatic colorectal cancer (mCRC) patients. Of the 199 patients enrolled in this study, 195 patients received either a FOLFOX chemotherapy or FOLFIRI chemotherapy regimen in combination with bevacizumab every 14 days and were randomized to receive either a 150 mg daily dose of GDC-0449 or a placebo. The primary objective of the trial was to measure the period of PFS from randomization to disease progression or death. Secondary outcome measures included the measurement of Hedgehog protein expression in archival tissue and tracking of adverse events. The trial did not meet its primary endpoint of extending the time from randomization to disease progression or death in study patients who received GDC-0449 in addition to the current SOC of bevacizumab and chemotherapy when compared to those patients who received only the current SOC treatment. GDC-0449 is being developed by Roche and Genentech under a collaboration agreement between Curis and Genentech. It is expected that data from the study will be submitted for presentation in a future medical meeting.

Source: Curis

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