Results

Roche shares surge as a double-shot win in I/O and hemophilia raises blockbuster expectations

Roche has scored a win with one of the key immuno/oncology trials of the year, posting significant top-line gains for progression-free survival and risk of death for a segment of lung cancer patients getting first-line treatment with a triple combo of its checkpoint therapy Tecentriq, Avastin and chemo. And it swept a double header early this morning with their report of another successful late-stage study for its newly approved hemophilia A drug Hemlibra, further setting the stage for a painful showdown with market leader Shire.

The back-to-back successes drove up Roche’s shares $RHHBY by more than 6% this morning, adding $12 billion in market cap as investors rallied to evidence that the pharma giant could successfully put the patents to a trio of franchise drugs in the rear view mirror while joining Merck in the front ranks of lung cancer contenders. Merck shares dipped 2%.

First, Tecentriq.

Sandra Horning

Some analysts had already raised doubts that Roche could field a triple with Avastin and chemo in the all-important market for first-line treatment of people with advanced non-squamous non-small cell lung cancer. Avastin could look too toxic and Merck’s Keytruda/chemo combo looked like the right approach for now.

But IMpower 150 succeeded where AstraZeneca’s combination of Imfinzi (durvalumab) and the CTLA 4 immunotherapy tremelimumab had flunked out — at least in the first shot at PFS. Roche’s top-line report notes that it still has to capture a mature snapshot of overall survival data in the first half of next year.

In the meantime the leaders in I/O, including Merck $MRK, now face a new rival in one of the biggest cancer markets they’re scrapping over in a frenzied race for market supremacy. That will likely have serious consequences for Merck, which worked hard to wrestle the lead from Bristol-Myers Squibb $BMY — another player still in contention. And AstraZeneca $AZN has made lung cancer a top priority for its own I/O franchise.

The win by Roche also bolsters the argument in favor of adding chemo to the drug regimen, with an ongoing debate over the advantages and disadvantages of including chemo or another immunotherapy.

“Many experts in the field will be relieved because there has been uncertainty … I think this will really encourage many of us to use this combination upfront,” oncologist Stefan Zimmermann told Reuters.

Roche chief medical officer Sandra Horning says that the company is now testing the triple in a range of cancer types. And the full data set on the triple will arrive at a conference in December.

Now Hemlibra.

Johnny Mahlangu

Roche just won an accelerated approval of this drug for hemophilia A on Friday, with data from HAVEN 1 and 2. In HAVEN 3, Roche repeated its earlier success and added a beat, demonstrating superiority to factor VIII prophylaxis. And it did it without triggering any new cases of thrombotic events that dogged its earlier trials, forcing regulators to add a black box warning on the label.

“It is well established that prophylaxis is the preferred approach for treatment of hemophilia A, but this can require frequent intravenous infusions, and some patients on prophylaxis can still experience bleeds, while others prefer on-demand treatment,” said Johnny Mahlangu, who’s on the faculty of health sciences at the University of the Witwatersrand and NHLS in Johannesburg, South Africa. “Given its potential to be dosed through subcutaneous injection only once weekly or every other week, Hemlibra may provide a further effective prophylactic treatment option for more people with hemophilia A and help alleviate some of the administration burden associated with current treatment.”

The successes weighed on hemophilia player Shire, which is facing a more powerful contender for its market share in hemophilia, and AstraZeneca. Both rivals saw their shares slip against the Roche spike this morning.



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