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Genentech announced on December 6 that the FDA approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy (paclitaxel and carboplatin) for first-line treatment of metastatic non-squamous non-small cell lung cancer without EGFR or ALK mutations. .

The approval is based on data from a multicenter, open-label, randomized, controlled Phase III IMpower150 study. Roche reported last year that the combination regimen (group B) significantly delayed disease progression or death compared with Avastin+ chemotherapy (group C), and the data released in March this year demonstrated a significant prolongation of overall survival (19.2 vs 14.7 months). ), improved ORR. Sandra Horning, Roche’s chief medical officer, said after approval that the Tecentriq immunocombination regimen has shown significant survival benefit in first-line treatment of patients with metastatic non-squamous NSCLC.

Source: FDA instructions

 

Late approval

In May of this year, the FDA has accepted Roche’s Supplemental Biologics Licensing Application (sBLA) and granted it priority review. However, in September, the FDA said it would take an additional three months to review the evidence and data to confirm whether it passed sBLA.

Tecentriq is an anti-PD-L1 monoclonal antibody that binds to PD-L1 on tumor cells and tumor-infiltrating immune cells, blocks its interaction with PD-1 and B7.1 receptors, and reactivates T cells. Kill cancer cells. Tecentriq has been approved by the FDA in 2016 for the treatment of NSCLC undergoing disease progression during or after chemotherapy with platinum and chemotherapy or ALK or EGFR mutation-positive patients undergoing FDA-approved targeted therapy.

Avastin is a biological antibody that specifically binds to vascular endothelial growth factor (VEGF) protein, which blocks the blood supply of the tumor and inhibits its spread by preventing the protein from interacting with receptors on vascular cells. There is now evidence that in addition to anti-angiogenic effects, Avastin can further enhance the anti-cancer immunity of TECENTRIQ by inhibiting VEGF-related immunosuppression, promoting T cell tumor infiltration, and activating T cell responses against tumor antigens. ability.

 

“Luxury Cocktail Therapy”, Yes OR No?

For the approval of Roche’s “luxury cocktail therapy”, investors are more cautious and there has been no major change in stocks. There are two main reasons for this, on the one hand because it is a very expensive therapy; on the other hand, it is necessary to face the competition of Merck East Keytruda combination therapy.

Just in June of this year, the FDA approved the combination therapy of Keytruda and Lilly Alimta as a first-line treatment for patients with metastatic NSCLC, and patients receiving this therapy do not need to consider the status of PD-L1 expression in vivo.

But Roche is happy to take advantage of this opportunity to compete in this area, which is the most profitable market for immuno-oncology drug manufacturers because of the large number of untreated patients requiring treatment. At the end of last month, Tecentriq combined with chemotherapy (albuminol) for sBLA for first-line treatment of PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer was also granted priority review by the FDA, and is expected to be done by the FDA in March 2019. Final review decision.

BMS’s immunotherapy combination Opdivo-Yervoy (PD-1+CTLA-4) first-line treatment of lung cancer encountered regulatory barriers in October; just now, AstraZeneca’s immunotherapy combination (PD-L1+CTLA-4) compared Standard chemotherapy did not significantly improve overall patient survival.

Therefore, “Mershadong is likely to dominate this market, and Roche will be the second, BMS and AstraZeneca will be in the third and fourth positions…”. Oddo BHF analyst Pierre Kobe wrote in a report to clients. He speculates that with the approval of this combination therapy, Tecentriq’s sales peak will increase by 1.5 billion Swiss francs ($1.51 billion).

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