Roche stays competitive in I/O race
- Swiss pharma Roche on Sunday reported treatment with its PD-L1 inhibitor Tecentriq (atezolizumab) led to substantial improvement in overall survival (OS) among previously treated patients with non-small cell lung cancer, compared to the standard chemotherapy docetaxel.
- Importantly, a positive effect was seen regardless of PD-L1 expression, giving Roche a chance to make inroads on Merck and Bristol-Myers Squibb's lead in immuno-oncology. All three companies presented data on their respective checkpoint inhibitors at the European Society of Medical Oncology (ESMO).
- Median overall survival hit 13.8 months in the Tecentriq arm, comparing favorably to the 9.6 months seen among patients treated with chemo. Among patients with a PD-L1 expression greater than 1%, treatment with Tecentriq boosted OS by an even greater amount, 5.4 months.
Roche, perhaps unsurprisingly, is upbeat about its immuno-oncology drug's success in metastatic non-small cell lung cancer (NSCLC). Merck and Bristol-Myers Squibb have led the way in immuno-oncology so far, but Bristol-Myers recent stumble with Opdivo could give Roche a chance to catch up.
Approval for Tecentriq in previously treated PD-L1 positive NSCLC could come as soon as next week, with the Food and Drug Administration having set a target action date of October 19 to conclude its review of Tecentriq in that indication.
Importantly, however, data from the Phase 3 study released over the weekend showed Tecentriq beat out chemo regardless of PD-L1 expression.
“Tecentriq is the first and only anti-PD-L1 cancer immunotherapy to help people with metastatic NSCLC live significantly longer than chemotherapy regardless of their PD-L1 expression level or their disease histology,” said Sandra Horning, chief medical officer at the Swiss pharma. “Even people whose disease had low or no observed PD-L1 expression still showed a significant benefit from the medicine.”
The results released at ESMO offer a more detailed view of topline data released at the beginning of September. Among the first 850 randomized patients, Tecentriq lengthened median OS by 4.2 months over chemotherapy. For those with a PD-L1 expression greater than 1%, median OS in the treatment arm hit 15.7 months, compared to 10.3 months on chemo.
Tecentriq was approved in the U.S. earlier this year for the treatment of locally advanced or metastatic bladder cancer, becoming the first anti-PD-L1 cancer immunotherapy to be approved by the FDA. Both Merck's Keytruda and Bristol-Myer's Opdivo target the closely related PD-1.
ESMO also cemented the dramatic reversal of fortune for Bristol-Myers Squibb, which earlier this year revealed Opdivo had failed to meet its endpoint in first-line NSCLC. Merck, which has focused specifically on patients with high levels of PD-L1 expression, notched a win in that setting which could open the door for Merck to steal a march on Bristol-Myers.
Analysis from Jeffries puts Tecentriq's efficacy data slightly ahead of Opdivo in non-squamous patients, despite its higher recruitment of third-line patients. This, along with Tecentriq's more convenient dosing, could put even greater pressure on Bristol-Myers in the developing market.
Roche has eight different Phase 3 studies ongoing to evaluate Tecentriq's efficacy in lung cancer, either as a monotherapy or in combination. Thompson Reuters forecasts potential sales for Tecentriq across all cancers hitting $4 billion in 2021.
- Roche Statement
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