EMA follows FDA to approve Roche's Tecentriq combo for frontline use in triple negative breast cancer
Months after Roche secured US approval for its checkpoint inhibitor Tecentriq, in combination with Celgene’s Abraxane, for frontline use in an aggressive, tough-to-treat subgroup of breast cancer patients — the EU has followed suit.
On Thursday, the Swiss giant said the Tecentriq combo is the first cancer immunotherapy regimen to be cleared by European regulators for triple-negative breast cancer (TNBC).
The approval, which covers patients whose tumors express PD-L1, is key for the Swiss drugmaker that is third-in-line — behind Merck $MRK and Bristol-Myers Squibb $BMY — for the checkpoint inhibitor Iron throne. Roche must take the lead in crucial cancer areas if it wants to hold on to its position, as AstraZeneca carves out a niche for its PD-L1 checkpoint Imfinzi in a subset of non-small cell lung cancer patients.
Roche’s TNBC approval is based on data from the pivotal IMpassion130 study, which enrolled 902 patients. Patients on the Tecentriq combo reduced the risk of disease worsening or death by 38% compared to Abraxane alone (median PFS 7.5 versus 5 months; p<0.0001) in patients whose tumors tested positive for PD-L1 expression.
The combination also conferred a clinically meaningful overall survival (OS) improvement versus comparator in the PD-L1-positive population (median OS=25 vs 18 months), Roche said, citing an interim analysis.
The EU approval also comes months after Merck’s flagship checkpoint inhibitor Keytruda posted positive data from an ongoing late-stage study called KEYNOTE-522. In July, the US drugmaker disclosed that the PD-1 therapy, in combination with chemotherapy, induced a statistically significant improvement in pathological complete response rates — a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery — compared with chemotherapy alone, in TNBC patients regardless of PD-L1 status.
Months prior, however, Keytruda failed to impress in a pivotal study as a monotherapy and as a second or third line of defense for TNBC patients.
About 10-20% of all breast cancers are triple-negative breast cancers (TNBCs), which characteristically has a high recurrence rate within the first five years after diagnosis. In TNBC patients, the growth of the cancer is not fueled by the hormones estrogen and progesterone, or by the HER2 protein, making it hard to treat.
About 70% of breast cancers diagnosed in people with an inherited BRCA mutation, particularly BRCA1, are diagnosed with TNBC. PARP inhibitors such as AstraZeneca’s Lynparza and Pfizer’s Talzenna are already approved for germline BRCA-mutated breast cancer and are being investigated in combination with checkpoint inhibitors for TNBC. Meanwhile, antibody-drug conjugates are another potential treatment option for TNBC under investigation.
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