Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Madrid – it’s Day 2 of the European Society for Medical Oncology (Twitter #ESMO14) annual meeting and the Congress is now in full swing. Today one of the highlights is the Presidential Session that takes place this afternoon. It’s where all attendees have the opportunity to hear what ESMO think is the most noteworthy data at the meeting, irrespective of the type of cancer.

Yesterday, we launched our Live ESMO blog series for Day 1, with commentary and insights posted throughout the day. If you missed the afternoon and evening notes, you can check them out.

Meanwhile, we’re really looking forward to hearing the CLEOPATRA trial overall survival (OS) data in HER2+ metastatic breast cancer at 4pm CET this afternoon.

CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, Phase III, randomised, double-blind, placebo-controlled study. The study evaluated the efficacy and safety profile of pertuzumab (Perjeta) combined with trastuzumab (Herceptin) and docetaxel chemotherapy compared to trastuzumab and chemotherapy plus placebo in 808 women with previously untreated HER2-positive metastatic breast cancer (mBC) or with HER2-positive mBC that that had recurred after prior therapy in the adjuvant or neo-adjuvant setting.

Sally wrote on Pharma Strategy Blog about the PFS data for the trial which was first presented at the 2011 San Antonio Breast Cancer Symposium (SABCS).

As Sally noted back in 2011:

“The idea behind combining pertuzumab (Perjeta) and trastuzumab (Herceptin) upfront is to enable a more comprehensive shut down of the HER2 pathway and delay resistance setting in.”

We’re now looking forward to the final overall survival data that will be presented for the first time at a conference by Dr Sandra Swain (Washington DC) in the Presidential Session at ESMO this afternoon.

There’s a press briefing between 8 and 9 where this data will be featured, so expect news releases to follow soon after this. Out of respect to researchers and those who come to these meetings to hear the data, we typically don’t write about data until after it’s been presented, so expect our initial commentary and analysis to follow later in the day on the blog.

What else are we looking out for at the Congress today and which sessions will the Mav be in?

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2 Responses to “ESMO 2014 Live Blog Day 2 #ESMO14”

  1. martijn bijker

    Perhaps a naive question/comment in the Cleopatra trial data discussion, but how do we know if the increased PSF and OS of pertuzumab (P) added to trastuzumab(T) (and chemo) is due to the overlapping MOA/targetting of the two mAbs to HER2 rather than the effect of P alone? Isnt the only way to defenitive show this by comparing:
    -Chemo T vs.
    -Chemo P vs
    -Chemo T+ P?
    When the latter two give better result than the first and are comparable the conclusion is that P added to chemo is better than T an chemo but there is no rational to add two mAbs

    • 3NT

      Thanks for the comment Martijn. The quick answer is there is a solid scientific rational for pertuzumab being the cause of the benefit seen in CLEOPATRA – it blocks dimer formation between HER2 and HER1, 3 & 4 pairs leading to comprehensive blockade of HER2-driven signaling.

      Historically, we also know that adding trastuzumab to chemo improves survival and so the current trial asks whether adding pertuzumab will delay acquired resistance via HER3 signaliing. Using pertuzumab alone is unlikely to be effective because the tumour is addicted to the HER2 oncogene. The 2 drugs have very different purposes.

      The 2012 NEJM paper by Baselga et al gives the key references if you want to some more of the background:

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