FirstWord Lists: A revolution in cancer – a launch calendar for key immuno-oncology indications

With immuno-oncology (IO) products set to dominate the weekend headlines from this year's ASCO annual meeting, we take a brief look at the latest revenue expectations for the most advanced IO products and how the next 12 months will see this race transition from the development to commercial arenas.

Consensus forecasts sourced from Bloomberg Industries suggest that just five IO products – of which only one is currently approved and marketed (Bristol-Myers Squibb's Yervoy for melanoma) – will generate combined revenues of $13 billion by 2020.

Among this emergent clutch of therapies, Bristol-Myers Squibb's PD-1 inhibitor nivolumab is forecast to be the biggest winner, with sales poised to reach $4.6 billion by 2020. Combined with forecast annual sales of $2.6 billion for Yervoy by 2020, Bristol-Myers Squibb stands to be the most heavily leveraged player in the IO market, with these therapies accounting for around a third of its total forecast revenues at start of the next decade.

Analysts currently expect Merck & Co.'s MK-3475 to emerge as the second largest player in the PD-1/PD-L1 space by 2020, with consensus sales of $3.3 billion forecast for the product.

MK-3475 now appears poised to become the first drug in this class to reach the market, for second-line Yervoy-refractory melanoma, by the end of 2014. Furthermore, feedback from oncologists polled by FirstWord last week – on the subject of 5 key pre-ASCO questions – indicates that based on the impressive data for MK-3475 to date, this approval will facilitate substantial off-label use in first-line patients (underestimated in the consensus forecasts provided).

The below list of anticipated launch dates for each of the leading PD-1/PD-L1 products across melanoma, non-small-cell lung cancer and renal cell carcinoma (source: Goldman Sachs) demonstrates, however, why analysts expect nivolumab to emerge as the leading product by 2020. Next year will be a critical one for Bristol-Myers Squibb as it looks to position nivolumab as an integral component in the treatment of NSCLC.

The calendar also provides a tangible reminder that despite a certain amount of bluster about the competitiveness of this race, AstraZeneca and Roche are not likely to launch their products before late 2016, over two years from now. There is much to play for and, as Goldman Sachs analysts note themselves, current regulatory timelines are likely to accelerate if more impressive data is generated. Investors will be looking at ASCO 2014 for the latest clues.
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2014 – MK-3475 for metastatic melanoma (2nd line [Yervoy-refractory] melanoma)
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Mid-2015 – nivolumab for NSCLC (3rd line squamous)
H2 2015 – nivolumab for NSCLC (2nd line squamous)
H2 2015 – nivolumab for NSCLC (2nd line non-squamous)
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H1 2016 – MK-3475 for metastatic melanoma (2nd line)
Mid-2016 – nivolumab for metastatic melanoma (1st and 2nd line)
Mid-2016 – MK-3475 for PD-L1-positive NSCLC
H2 2016 – nivolumab for RCC (2nd line)
Late 2016 – MPDL3280A for NSCLC (2nd and 3rd line)
Late 2016 – MEDI-4736 for PD-L1-positive NSCLC (3rd line)
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Mid-2017 – nivolumab + Yervoy in melanoma
Late 2017 – MPDL3280A + Avastin on RCC (1st line)
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H1 2018 – nivolumab + Yervoy in RCC
H1 2018 – nivolumab + Yervoy in NSCLC
H1 2018 – MEDI-4736 in NCSLC (2nd line, stage III)
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