Cisplatin/Alimta Receives FDA Approval for First Line Advanced NSCLC, Non-Squamous Only

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September 30, 2008 - 9:17 pm email to a friend printer friendly view / write comments

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Dr. West

   Yesterday, as described in a press release, the FDA approved the regimen of cisplatin and alimta as a first line therapy for advanced NSCLC, based on the positive results from a trial called “JMDB” by the sponsor company (Eli Lilly).  I described the highlights in a prior post, also recently published (abstract here).  It compared cisplatin/gemcitabine to cisplatin/alimta (pemetrexed) in 1725 patients with previously untreated advanced NSCLC and found that the overall efficacy was the same between the two regimens, with a little more favorable side effect profile on the alimta arm.  That wasn’t the interesting part. 

   The part that generated interest within the lung cancer community was the fact that the different main subtypes of NSCLC (tumor histology) did better with one chemo regimen or the other.  Patients with squamous NSCLC did better on cisplatin/gemcitabine, while the patients with adenocarcinoma or large cell NSCLC did better on cisplatin/alimta, as shown in both the survival curves and the table below:

 (click to enlarge)

   Based on these results, the FDA approved the combination of cisplatin and alimta as a first line therapy, for patients with non-squamous NSCLC only.   In addition, based on these findings and other work (see prior post), the FDA also amended the current approval of alimta as a second line therapy to only include treatment for patients with non-squamous NSCLC. 

   This is particularly important because up until very recently, there was no reason to suspect that alimta wasn’t useful for the broader population of patients with advanced NSCLC, squamous and non-squamous alike.  But I’ve done a series of lectures for general oncologists over the last couple of months, preceded by a series of case-based questions about how they would manage certain clinical situations, and it’s been clear that only a minority of practicing oncologists are aware of the now compelling evidence that alimta is simply not an effective treatment for squamous NSCLC (it didn’t beat placebo in a recent trial), while its activity is particularly pronounced for non-squamous NSCLC, where all of its previously noted activity appears to be concentrated.

    The other important factor is that, along with the histology-specific results with avastin, there’s more evidence that we need to tailor our treatments for patients by keeping their NSCLC subtype in mind.  This means that we need to get enough tumor tissue at the time of biopsy to clarify the subtype.  We are entering an era where our treatments for lung cancer now need to be individualized.

Posted in: Chemotherapy, First-line treatment, Lung Cancer, Non-Small Cell Lung Cancer (NSCLC), Second-line treatment, Stage IV/Advanced/Metastatic NSCLC, Treatment                     email to a friend printer friendly