The European Commission has granted approval for the use of ALIMTA ( Pemetrexed for injection ) as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced nonsquamous non-small cell lung cancer ( NSCLC ).
The approval is based on clinical trial results showing an improvement in progression-free survival, as well as a preliminary analysis showing a strong trend toward better overall survival, for NSCLC patients treated first with Pemetrexed plus Cisplatin and then continue treatment with Pemetrexed alone in the maintenance setting.
Alimta is the first chemotherapy agent to be approved in Europe for continuation maintenance therapy. In this setting, patients whose disease has not progressed immediately following first-line treatment with Pemetrexed plus Cisplatin can continue maintenance treatment with Pemetrexed alone and achieve additional benefit.
Continuation maintenance therapy with Pemetrexed is specifically tailored to benefit the group of patients with a particular type of NSCLC, called nonsquamous, and who have shown a positive response or disease stabilization after treatment with first-line Pemetrexed plus Cisplatin.
Although other maintenance regimens are currently available for NSCLC, they involve using different medicines in the maintenance phase of treatment than were used in the first-line setting.
Approval of Alimta continuation maintenance was based on results from PARAMOUNT, a randomized double-blind phase III study presented in June 2011 at the American Society of Clinical Oncology ( ASCO ) Annual Meeting.
The study examined whether Pemetrexed continuation maintenance therapy improves progression-free survival, as well as overall survival, after Pemetrexed-Cisplatin induction therapy in patients with advanced nonsquamous NSCLC.
The study met its primary endpoint of progression-free survival, and a preliminary analysis has shown a strong trend toward positive overall survival.
Patients received standard induction therapy with four cycles of Pemetrexed ( 500 mg/m2 ) and Cisplatin ( 75 mg/m2 ) on a 21-day cycle. Of the 939 patients with advanced nonsquamous NSCLC who were enrolled and received induction therapy, 539 non-progressers with a good performance status were subsequently randomized to receive one of two maintenance therapy regimens.
They received either Pemetrexed ( 500 mg/m2 on day one of a 21-day cycle ) plus best supportive care ( n=359 ), or placebo plus best supportive care ( n=180 ) until disease progression.
All patients received vitamin B12, Folic acid and Dexamethasone.
Alimta is approved in Europe and the U.S. for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with Cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following Platinum-based chemotherapy.
Alimta is also approved, in combination with Cisplatin, in both the EU and U.S. for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.
Maintenance therapy is a relatively new concept in lung cancer treatment, in which patients start maintenance therapy immediately following their first-line treatments to try to maintain disease control.
No other chemotherapy is currently approved in the continuation maintenance setting, in which one of the same medicines used in first-line treatment is continued as maintenance therapy. ( Xagena )
Source: Eli Lilly, 2011