Roche ($RHHBY) is pinning its hopes on cancer powerhouse Kadcyla, priming the drug for new indications as it looks to soften the blow once biosimilars for top-selling meds come knocking. But now the company is facing a stinging setback after Kadcyla flunked a Phase III trial for stomach cancer.
The "armed antibody" did not significantly improve overall survival compared to old treatments docetaxel or paclitaxel in a trial of 412 gastric cancer patients already treated with first-line therapy, Roche said in a statement. The news is particularly disappointing given the company's high expectations for the drug.
Roche wanted to file for approval of Kadcyla for gastric cancer next year, PMLive points out. The drug's predecessor Herceptin has been approved for years to treat HER2-positive gastric cancer.
This is not the first time Kadcyla has delivered underwhelming trial results. Back in December, Kadcyla and another Roche cancer drug, Perjeta, failed to beat Herceptin and chemo in a late-stage study. The company had hoped to show that its new drugs could improve progression-free survival in untreated patients without traditional chemo, Roche spokeswoman Ulrike Engels-Lange told FiercePharma at the time.
Still, there are other indications for which Kadcyla may prove effective. The drug is in three trials that could help it expand into early breast cancer, and is also in a Phase II trial in HER2-positive non-small cell lung cancer (NSCLC). New indications for Kadcyla could give Roche some extra cushioning as it stares down biosimilar rivals for its bestsellers.
The Swiss drugmaker recently unveiled third quarter numbers that beat analysts' expectations, but that happened because of its tried-and-true cancer drugs. Rituxan, Avastin and Herceptin kicked in enough revenue that the Swiss drugmaker was able to brighten its 2015 forecast. But biosimilar copies of those drugs are expected to hit the market in Europe at the end of 2017 and the U.S. market after 2019, CEO Severin Schwan said on the second quarter's earnings call, potentially dealing the company a costly blow.
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| Roche CEO Severin Schwan |
Kadcyla could help Roche at a critical moment. The drug brought in 558 Swiss francs ($574 million) during the first 9 months of this year, a 57% hop over the same period last year. And Kadcyla is going strong in Europe, with recent launches in France and Spain delivering positive numbers.
But the med is also facing issues in the U.K., where the country's price watchdog and special cancer drugs fund are taking a strict stance. In August 2014, the National Institute for Health and Care Excellence (NICE) rejected Kadcyla, saying the drug was too expensive even after Roche offered discounts. The Cancer Drugs Fund recently followed suit, cutting the med from its list of covered treatments and prompting some fighting words from Schwan, who called the fund's decision to stop funding certain cancer meds "stupid" and "completely arbitrary."
- read Roche's statement (PDF)
- here's the PMLive story
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