Roche has notched a twelfth indication on the belt of its blockbuster cancer therapy Tecentriq (atezolizumab), following the US Food and Drug Administration’s (FDA) decision to approve the drug in a subset of patients with colon cancer.
Following its newfound regulatory green light, Tecentriq and its subcutaneous formulation counterpart, Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), alongside chemotherapy agents fluoropyrimidine and oxaliplatin, have become the first immunotherapy-based combination to be blessed by regulators for the treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer in the post-surgery setting.
The FDA’s call to give Tecentriq the go-ahead in this form of colon cancer stems from the positive Phase III ATOMIC study (NCT02912559), in which researchers found that combining Tecentriq with a modified FOLFOX6 chemotherapy regimen slashed the risk of disease recurrence or death by 50% compared with chemotherapy alone.
Tecentriq’s latest label expansion comes as just under a quarter of all colon cancers are caught and diagnosed at the stage III mark – with one in three of the patients in this subgroup experiencing disease recurrence within five years. Currently, colon cancer is one of the most common subtypes globally and is a leading cause of cancer-related deaths.
According to Roche’s CMO and head of global product development, Levi Garraway, Tecentriq’s approval could mark a “new standard of care” in the stage III dMMR colon cancer setting – potentially offering renewed hope for patients who are often at a higher risk of disease recurrence.
Meanwhile, ATOMIC US principal investigator and Mayo Clinic oncology professor, Frank Sinicrope, notes that a more targeted approach to treating dMMR colon cancer post-surgery holds “practice-changing” potential for this subgroup of patients, as care in the adjuvant setting had never previously counted in or accounted for an individual’s potential recurrence risk due to their mismatch repair status.
While Tecentriq’s US label expansion will be welcome news for Roche, the company does not plan to stop extending the drug’s reach there, as it is currently pursuing further regulatory filings with the European regulators in dMMR colon cancer.
The Swiss pharma giant makes these efforts as Tecentriq edges closer to potential biosimilar competition, as its key patents are slated to begin expiring in 2029. Due to this looming loss of exclusivity, analysts at GlobalData, parent company of Pharmaceutical Technology, forecast that the drug’s sales will peak at just under $4.5bn in 2028, before taking a 23% dip to the end of the forecast period in 2032.
