Novartis Announces Phase 3 Trial for Lung Cancer Therapy

Novartis, Basel, Switzerland, announced that ASA404, its novel cancer agent, has entered a Phase 3 lung cancer trial following positive outcomes of a Phase 2 trial. The novel mechanism of action of ASA404 may represent a new approach to treating the most prevalent cause of cancer death, according to a company statement.

ASA404 is a Tumor-Vascular Disrupting Agent (Tumor-VDA) that selectively causes the collapse of existing tumor blood supply leading to extensive tumor cell death. The action of ASA404 is distinct from that of angiogenesis inhibitors, which inhibit the formation of new tumor blood vessels.

In a randomized Phase 2 study, ASA404, in combination with chemotherapy, demonstrated a median overall survival advantage of more than five months in first-line treatment of advanced non-small cell lung cancer (NSCLC) compared with chemotherapy alone. A similar survival advantage was observed in a subsequent extension of the Phase II study.

Non-small cell lung cancer, the potential lead indication for ASA404, accounts for about 85% to 90% of all lung cancers.

ASA404 is one of six novel oncology compounds Novartis is developing for potential registration over the next five years. The other investigational therapies which focus on a broad array of cancer targets include RAD001 (renal cell carcinoma and other cancers), SOM230 (Cushing’s disease/refractory carcinoid tumors, acromegaly), LBH589 (cutaneous T-cell lymphoma and other cancers), EPO906 (ovarian cancer), and PKC412 (acute myelogenous leukemia and aggressive systemic mastocytosis).

The Phase 3 trial, named ATTRACT-1 (Antivascular Targeted Therapy: Researching ASA404 in Cancer Treatment), will be conducted at more than 200 sites in 20 countries.

The trial will be a randomized, double-blind, placebo-controlled, multi-center study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (Stage IIIb/IV) NSCLC of squamous or nonsquamous histology. The trial will consist of 1,200 patients who will be assigned to one of the following treatment arms in a ratio of 1:1: ASA404 1800 mg/m2 plus chemotherapy (carboplatin/paclitaxel) or placebo plus chemotherapy (carboplatin/paclitaxel) as a control. Treatment will be given for up to six cycles, with one cycle equaling 21 days and total treatment equaling 126 days (4.2 months).

Novartis signed an exclusive licensing agreement with Antisoma plc for the worldwide rights to ASA404 in April 2007.

Release date: April 11, 2008
Source: Novartis