What on the face of it looks like a decent enough set of third-quarter numbers from Roche belies mounting pressure on the company from biosimilars and a worrying slowdown in sales of its anti-PD-L1 star, Tecentriq.
Were it not for strong growth of Perjeta and the promise of a multiple sclerosis blockbuster, Ocrevus, the Swiss firm would be struggling. Either way it cannot afford to rest easy, and it will be conscious that the heat is now on Tecentriq to deliver in Impower-150, its important first-line lung cancer trial, due to read out by the end of the year.
This is a vital study because lung cancer is by far the biggest potential use for Tecentriq, and since the broad US approval of Merck & Co’s Ketyruda the battle has been all about first-line use. Impower-150 is the first of several first-line NSCLC studies to read out for Tecentriq, though because all are event-driven their timing can only be estimated.
Indeed, Roche today repeated that it would only become apparent once Impower-150 was unblinded whether overall as well as progression-free survival would be reported (Event – The next showdown in first-line lung cancer, September 13, 2017). If only PFS reads out now OS numbers would come three to six months later, the group said on an analyst call.
Just how important NSCLC is can be seen by looking at Tecentriq’s 2017 sales: quarter-on-quarter revenue rose from CHF113m ($115m) to CHF124m in the second quarter, but the last three-month period saw a fall back to CHF118m, Roche said today. One possible reason is failure in Imvigor-211, a confirmatory trial for urothelial cancer, Tecentriq’s first use, though approval is unlikely to be rescinded.
More immediate pressure is falling on Roche’s antibody business, with third-quarter Rituxan sales in Europe of CHF406m, a 12% fall quarter on quarter, or 16% year over year.
Bernstein analysts noted that this took place in only the second quarter of biosimilar competition. Novartis’s version, Rixathon, was approved in Europe in June, and a US filing was accepted in September; the brand’s sales falloff could spur concerns about biosimilars causing faster than expected erosion.
Longer-term biosimilar threats to Avastin – a US version was recently approved – and Herceptin cannot be ignored either. Avastin continues to drift downwards, with quarterly sales down 4% year on year; this was down to the removal of reimbursement for metastatic breast cancer in France and pressure from novel lung cancer immunotherapies, and Roche also cited general pricing pressure in Europe.
As such, it is just as well that the group’s pipeline is capable of delivering such revolutionary drugs as Alecensa and Ocrevus, which Roche today said looked to be among the best multiple sclerosis launches ever. However, Rituxan and Avastin are big shoes to fill.
A likely miss
Which is why Tecentriq is so vital. The sales numbers are small, but based on its nine-month run rate it looks likely to miss full-year consensus revenue expectations, which EvaluatePharma calculates as $545m.
And already, with Impower-150 readout imminent, the sellside has started quietly rowing back on expectations. Evercore ISI’s Umer Raffat reckons Tecentriq plus chemo should beat chemo first-line, but that the benefit of adding Avastin into the mix is questionable.
Bank of America Merrill Lynch analysts say they are “cautious” about Impower-150, but say all would not be lost in the event of failure, since other first-line chemo combo trials are ongoing.
Impower-130 is one of the most interesting, thanks largely to its simpler design – adding Tecentriq on top of Abraxane-containing chemo, without the complication of Avastin – which could help statistics and powering. Roche will not comment on the hierarchical analysis or how much alpha it had assigned to the various complex readouts in Impower-150.
“We have a good chance of winning one of these bets,” Roche’s R&D chief, Daniel O’Day told analysts, referring to the various Impower studies, which he stressed would drill down precisely into which particular chemo combo was best. “We’re just not sure which one.”
|Tecentriq studies in 1st-line NSCLC|
|Study||Tecentriq combo||Histology/patient population||Endpoint(s)||Data?||Trial ID|
|Impower-150||+ paclitaxel + carboplatin +/- Avastin||Non-squamous||PFS & OS (poss 3-6mth later)||Q4 2017||NCT02366143|
|Impower-131||+ carboplatin + paclitaxel/Abraxane||Squamous||PFS & OS||Jan 2018||NCT02367794|
|Impower-130||+ Abraxane||Non-squamous||PFS & OS||May 2018||NCT02367781|
|Impower-132||+ pemetrexed + carboplatin/cisplatin||Non-squamous||PFS & OS||2018||NCT02657434|
|Impower-110||Monotherapy||Squamous & non-squamous, PD-L1+ve||OS||Jan 2019||NCT02409342|