By Noemie Bisserbe
Roche Holding AG said Thursday that its immunotherapy drug Tecentriq slowed the progression of lung cancer and helped patients live longer in a late-stage study, offering a new hope for patients and bolstering the Swiss drugmaker's defense against a wave of cut-price competition to its top-selling medicines.
The Basel-based drugmaker said patients who received Tecentriq, along with Roche's older cancer drug Avastin and chemotherapy, showed a 38% reduced risk of their disease worsening, compared with patients who were given only Avastin and chemotherapy. Tecentriq is already approved for patients suffering from advanced bladder cancer but breaking into lung cancer would significantly widen the market for this drug.
Roche's immunotherapy Tecentriq is pivotal to its strategy of bringing new drugs to market to replace older medicines, whose sales are set to decline as they lose patent protection, and as rivals launch cheaper, copycat versions. The company has in years past been a global leader in rolling out blockbuster cancer drugs, but many of its best sellers have lost -- or soon face losing -- patent protection in key markets.
They also face new competition in the form of "biosimilar" medicines. Biosimilars are near-replicas of biologic drugs, which are made out of living cells and are typically targeted against complex diseases including cancer or arthritis.
To counter all that competition, Roche has bet big on immunotherapy medicines. Those include a range of treatments that harness a patient's own immune system to target cancer. The approach doesn't work in all patients, but its success against some hard-to-treat cancers makes it one of the most closely watched area in cancer pharmaceuticals. Stll, these new drugs come at a steep price: Tecentriq costs around $12,500 a month in the U.S.
Roche is betting its push into immunotherapies can take up the slack from an expected sales downturn as three of its best-selling cancer drugs face new competition. Its cancer drugs Herceptin, Avastin and Rituxan account for more than $20 billion in annual sales, or over 40% of the company's total revenue. Analysts estimate that the trio accounts for around 65% of the company's annual profit.
But competition from biosimilars has begun eroding revenues. Rituxan sales dropped by more than 13% in Europe after it lost patent protection, and rivals launched biosimilar versions of the drug this year. Last month, European regulators approved a breast-cancer biosimilar competitor to Herceptin, made by Samsung Bioepis Co. Ltd., the South Korean group's new biotechnology company.
Copies of Avastin are hot on their heels. Amgen Inc. and Allergan PLC are readying a biosimilar version, which could be available in the U.S. as soon as 2019.
Roche hopes Tecentriq can help it maintain its leadership and defend its margins in the increasingly competitive oncology market.
There have been setbacks. Roche's hopes of protecting its $7 billion breast-cancer franchise with a new drug cocktail were dealt a blow in June after a separate trial showed the combination was only slightly better than an older medicine made by the company. In September, Lampalizumab, a drug that Roche hoped would prevent loss of vision and become a top seller, failed a late-stage trial.
Days later, Roche said its skin-cancer treatment Zelboraf didn't reduce the risk of recurrence in patients who had undergone surgery to cut out tumors and had a genetic mutation called BRAF.
But there have also been some good news. Its multiple-sclerosis treatment Ocrevus, which was approved by the U.S. Food and Drug Administration in March, is quickly gaining traction. It clocked in sales of 500 million Swiss francs ($506 million) in the first nine months of the year.
Analysts have said they expect Tecentriq, which is being tested for a wide range of cancers, will rack up annual sales of around $3.6 billion by 2025. Sales for lung cancer, one of the most common and serious types of cancer, should account for a significant share of those revenues. The company hopes to receive FDA approval as the first treatment for lung cancer, meaning the one the agency recognizes as the best treatment.
Tecentriq enters a crowded market of immunotherapies. Bavencio, co-developed by Germany's Merck KGaA and Pfizer Inc., and AstraZeneca PLC's Imfinzi have showed mixed results so far. But Bristol-Myers Squibb Co.'s Opdivo and Merck & Co.'s Keytruda could prove serious contenders, according to preliminary trials.
Write to Noemie Bisserbe at [email protected]