Roche optimistic on Tecentriq despite late market entry
- Roche provided an upbeat overview of the first nine months of 2016. High points included the approval of the PD-L1 inhibitor Tecentriq (atezolizumab) in non-small cell lung cancer, and the six breakthrough therapy designations earned from the FDA during 2016.
- The Swiss pharma described its pharma pipeline as "on track", with data readouts planned for immuno-oncology therapeutics in 2017 and 2018.
- The company announced sales growth of 4% to CHF 29.1 billion ($29.4 billion) for the first nine months of 2016, driven by sales in immunology and oncology.
On the earnings call with analysts Thursday morning, Roche was upbeat about the first nine months of 2016.
Severin Schwan, CEO of Roche, opened the call by describing the launches of five new medicines in 12 months (Cotellic, Alecensa, Venclexta, Tecentriq and Ocrevus) as "unprecedented in the history of Roche". (Ocrevus is expected to be approved but hasn't yet.)
Describing the growth of 4% as "solid." Daniel O'Day, CEO of Roche Pharmaceuticals, started with oncology, which was the sector that raised the most excitement from the speakers, and caught the interest in the Q&A section too.
Tecentriq was one of the year's new launches, and O'Day said that the sales for bladder cancer in the US had started well, with around $77 million after only three months. There was also a lot of enthusiasm from the company about the recent Tecentriq approval for second- and third-line NSCLC in "all-comers." Despite being the third PDL1-related drug to market, O'Day was confident of Tecentriq's competitiveness, particularly pointing out its efficacy in a wide selection of subgroups and its three-weekly dosing schedule.
O'Day also touted Roche's cancer immunotherapy pipelines, including more than 20 drugs in development, and the broadest set of studies of combination regimens. Of these, ten are in clinical trials. Tecentriq itself is in seven studies, both alone and in combination. Results for the Phase 2 study of the combination of Tecentriq and Avastin in renal cancer will be in hand by the end of 2016, then probably released early in 2017.
The executive emphasized the role of combination studies in understanding the rationale behind selecting different combinations in treatment, and said to expect a variety of approaches for first-line treatment. More first line data for Tecentriq is expected next year, around the same time as first-line data for close competitors Keytruda (pembrolizumab) and Opdivo (nivolumab).
Still in oncology, the Perjeta (pertuzumab) Phase 3 adjuvant setting APHINITY study in breast cancer is expected to readout in the first quarter of 2017. Alecensa's uptake in lung cancer has also been described as "strong", and the drug has received breakthrough designation in first line advanced ALK-positive NSCLC. The global Phase 3 ALEX study comparing Alecensa and crizotinib in first-line treatment of ALK-positive advanced NSCLC should readout during early 2017.
Like a number of other big pharmas, Roche is also stepping into biosimilars waters, and expects to launch biosimilar versions of Herceptin (trastuzumab) and Rituxan (rituximab) in the EU in the second half of 2017. U.S. launches are likely to be towards the end of the decade.
- Roche Investor update
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