Roche Holding AG moved up a gear in the competitive field of immuno-oncology after reporting strong data in patients with non-small cell lung cancer who had not previously been treated, potentially catapulting the company to the fore in one of the most competitive fields of cancer research.
When used in as an initial or first-line treatment for NSCLC, the combination of chemotherapy, Avastin and Tecentriq cut the risk of the disease returning or death by 38% compared with Avastin and chemotherapy, in a late-stage study entitled IMpower150. The percentage of patients whose cancer had not worsened after 12 months, a measure known as progression-free survival, doubled with the Avastin, Tecentriq and chemotherapy combination and tumor shrinkage was also greater, Roche said.
The Basel, Switzerland-based pharmaceuticals and diagnostics group said early results from the co-primary endpoint of overall survival "are encouraging" although not fully mature; overall survival is a more important indicator of benefit in immuno-oncology rather than absolute progression-free survival, analysts say. The full data set from the IMpower150 study will be presented later Dec. 7 at the ESMO IO Conference in Geneva.
In the crowded NSCLC field, Tecentriq competes with Merck & Co. Inc.'s Keytruda, Bristol-Myers Squibb Co.'s Opdivo, AstraZeneca PLC's Imfinzi and Bavencio, developed by Pfizer Inc. and Merck KGaA. All are immuno-oncology treatments with late-stage trials ongoing.
"Facing only weak competition from Merck's Keytruda, we see the highly significant 38% reduction in risk of disease progression or death securing a swift adoption of Tecentriq on top of Avastin in first line NSCLC as we estimate that Avastin monotherapy is the preferred choice in one out of five oncologists in the U.S. and Europe," Baader Helvea analyst Bruno Bulic said in an emailed note. "We expect Roche to further strengthen its lung cancer franchise in 2018 with the IMpower 130 and 132 studies, truly competing for market domination thereafter." Bulic has a "buy" rating on Roche and forecast sales of Tecentriq in first-line NSCLC of 5 billion Swiss francs.
The data caps a flurry of good news for the Swiss drugmaker this week. Avastin was granted full U.S. regulatory approval for glioblastoma, an aggressive form of brain cancer, while its pioneering hemophilia treatment Hemlibra — previously known as ACE910 — showed promising results in bleeding control in interim results for the phase 4 Haven study. Roche is banking on pioneering treatments like Tecentriq and Hemlibra to propel sales and make up for the loss of exclusivity on older high-margin drugs like Avastin, Herceptin and Rituxan, expected in the next three years.
Market share increase possible
Tecentriq, which is in eight late-stage trials either alone or in combination, is a monoclonal antibody designed to bind to a protein called PD-L1 that is found on the surface of cancer cells. The medicine is already approved in more than 50 countries for lung cancer that has spread and already been treated, as well as for those whose urothelial cancer has spread and in whom chemotherapy is not an option.
"This Tecentriq study is the first positive phase 3 combination trial that showed a cancer immunotherapy reduced the risk of the disease getting worse when used as an initial treatment in a broad group of people with advanced non-squamous NSCLC," Sandra Horning, Roche's chief medical officer and head of global product development, said. "The IMpower150 study represents an important advance in lung cancer treatment, and we will submit these to regulatory authorities around the world."
Despite recent advances in the treatment of lung cancer by AstraZeneca and others, it is still the most common and one of the most lethal cancers in the world, accounting for one in five of all cancer deaths. Due to the fact that more than two-thirds of patients are diagnosed at a later stage of the disease, the prognosis is often poor. Non-small cell lung cancer is the most common form of the disease and accounts for about 85% of all cases.
Berenberg analyst Alistair Campbell said Roche's medical affairs director Stefan Frings was confident of more positive Tecentriq lung cancer data still to come next year when speaking at the bank's conference Dec. 6.
"This could significantly increase Roche's share of immuno-oncology in lung cancer, perhaps at the expense of Merck and Bristol-Myers Squibb," said Campbell, who rates the stock a "hold."