The study did meet one of its secondary endpoints of improved progression-free survival for the ALIMTA arm. Results will be presented on
"Phase II results with this combination were promising and we were hoping to demonstrate an improvement in survival for nonsquamous NSCLC patients, so we are disappointed with the results of this trial," said
Patients with previously untreated stage IIIB/IV nonsquamous NSCLC and a performance status of 0-1 (n=939) were randomized to receive ALIMTA (500 mg/m2) + carboplatin (AUC 6) + bevacizumab (15 mg/kg), along with dexamethasone and folic acid and vitamin B12 supplementation (n=472) or paclitaxel (200 mg/m2) + carboplatin (AUC 6) + bevacizumab (15 mg/kg), with dexamethasone (n=467). First-line treatments were conducted every three weeks for up to four cycles. Patients whose disease did not progress following first-line treatment received either maintenance of ALIMTA plus bevacizumab (n=292) on the ALIMTA arm, while those on the paclitaxel arm received bevacizumab as a single agent (n=298).
Overall survival for patients randomized to the ALIMTA arm achieved a median overall survival of 12.6 months versus 13.4 months for patients on the paclitaxel arm (HR 1.00; p=0.949), a result that demonstrated no statistical difference. POINTBREAK showed a statistically significant improvement in progression-free survival (6.0 months versus 5.6 months [HR 0.83; p=0.012]) in the ALIMTA arm. Secondary objectives also included overall response rate (34.1% versus 33.0%) and disease control rate (65.9% versus 69.8%), which did not show a difference between the two arms.
A pre-specified non-comparative survival analysis for a subgroup of patients treated with maintenance therapy showed a median survival of 17.7 months for the ALIMTA arm and 15.7 months for the paclitaxel arm and progression-free survival of 8.6 months and 6.9 months. Toxicity profiles differed between regimens. Significantly (p ≤ 0.025) more drug-related grade 3/4 anemia (14.5% versus 2.7%), thrombocytopenia (23.3% versus 5.6%) and fatigue (10.9% versus 5.0%) were seen on the ALIMTA arm. Significantly more grade 3/4 neutropenia (40.6% versus 25.8%), febrile neutropenia (4.1% versus 1.4%), sensory neuropathy (4.1% versus 0%) and grade 1/2 alopecia (36.8% versus 6.6%) were seen in patients on the paclitaxel arm.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer has long been the most common cancer in the world, representing nearly 13 percent of all new cancers and causing nearly 1.4 million deaths annually. About 85 to 90 percent of all lung cancers are NSCLC. The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.
NSCLC comprises a group of histologies or tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses, as well as histologies classified as "other."
About Lilly Oncology
For more than four decades, Lilly Oncology, a division of
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
Important Safety Information for ALIMTA® (pemetrexed for injection)
What is the most important information that I should know about ALIMTA?
ALIMTA can suppress bone marrow function, which may cause low blood cell counts.
ALIMTA may not be appropriate for some patients.
If you are allergic to ALIMTA, tell your doctor because you should not receive it.
If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.
Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA.
It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.
You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.
What should I tell my doctor before receiving ALIMTA?
If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.
Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs) for pain or swelling.
What are the possible side effects of ALIMTA?
Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects.
Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death.
The most common side effects of ALIMTA when given alone or in combination with cisplatin are:
Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn't go away.
These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist.
How is ALIMTA given?
ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).
For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information accompanying this booklet, visit www.ALIMTA.com, or call 1-800-545-5979.
You are encouraged to report negative side effects of prescription drugs to the
This press release contains forward-looking statements about the potential of ALIMTA for the treatment of non-small cell lung cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the
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