Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Yesterday at ASCO was frantic, there is no other way to describe it as one hurtled from one session to the next.  There is little time for reflection in a huge meeting of over 30,000 squeezed into a small space, but one thought crossed my mind while sitting in the lung and colorectal cancer sessions.  Namely, the abstracts often contain preliminary data from several months back and the data should be taken with a large pinch of salt.  A good example of this was OSI/Genentech's Tarceva, which at first glance suggested a small benefit of only 8 days as maintenance therapy.  The data being presented this morning is a little more robust than that, so the media should beware of jumping to hasty conclusions.

Typically, advanced lung cancer patients get 4 cycles of chemotherapy and then their progress is monitored until progression, whereupon another therapy is tried.  The big question raised recently, is whether adding a new treatment or combination as maintenance therapy would improve the survival.  At this ASCO meeting a number of trials attempted to answer this important question.

Let's look at Tarceva therapy compared to placebo in this setting.  The final results of the SATURN trial demonstrate that Tarceva actually significantly improved PFS in chemo naive patients with both squamous and non-squamous cell lung carcinoma by 41% compared to placebo.  Patients with an EGFR mutation achieved a 10 fold increase in the time they lived without their disease worsening.  Sadly though, the biomarker data suggested that KRAS mutation status was not a predictor of efficacy in NSCLC in patients treated with Tarceva, as had been hoped.

A second trial, called ATLAS, looked at the combination of Tarceva with Avastin following standard chemotherapy as maintenance therapy after first-line treatment with chemotherapy plus Avastin in patients non-squamous histology.  Patients treated with this combination saw their cancer growth slow more than a control group treated with Avastin alone.

Over 750 patients were randomized to receive Avastin and placebo, or Avastin and Tarceva. Patients in  the Tarceva group survived an average of 4.8 months before the cancer started growing again, compared to 3.7 months for the control group.  This eqautes to a 29 percent reduced risk of disease progression for patients who took the Tarceva and Avastin combination compared to Avastin alone.

Vincent Miller, the presenter stated that, "This is the first study to show that adding
erlotinib (Tarceva) to maintenance therapy with bevacizumab (Avastin)
delays disease progression in patients who have already received
bevacizumab as part of their initial chemotherapy."

In a third trial with Alimta (Lilly), 663 non-squamous patients with metastatic lung cancer were randomised to receive Alimta or placebo.  Preliminary results showed that patients who took the drug lived 26 percent longer compared to the control group, ie 13.4 months compared with 10.6 months.

The lead author and presenter said that, "Maintenance therapy with Alimta (pemetrexed) offers a new paradigm for patients who have advanced lung cancer, because it has a low toxicity and can be given on an ongoing basis over a prolonged period of time to extend patients' lives."

There was very little hot news to report from yesterday's colorectal cancer sessions, but the data in advanced lung cancer could well change the landscape and significantly improve survival for patients with the disease.  That's great news all around.  Mind you, I wouldn't like to be one of the companies with ongoing trials in this area though, the standard of care could well have changed with these results and the bar raised a little higher for new entrants.  That's good news for patients though!

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