FDA delays key Tecentriq decision by 3 months
- Swiss pharma Roche will have to wait three more months before it learns the Food and Drug Administration's verdict on its immunotherapy Tecentriq in first-line lung cancer, after the agency delayed an expected decision on the drug.
- According to Roche, the FDA said it would need the extra time to review information submitted alongside the company's application for Tecentriq's use as an initial treatment of non-squamous cell lung cancer (NSCLC) with Avastin and two older chemotherapies.
- A decision is now expected by Dec. 5, providing rival Merck & Co. a bigger window to further expand the dominant position of its immunotherapy Keytruda in the all-important lung cancer market.
News keeps breaking Merck's way. After a spring and summer in which Keytruda (pembrolizumab) solidified its advantage in lung cancer, the delay for Roche's Tecentriq (atezolizumab) application pushes back potential first-line competition to Merck's drug.
The FDA was originally scheduled to decide on approval of Tecentriq in combination with Avastin (bevacizumab) carboplatin and paclitaxel by Sept. 5. But the agency judged information Roche gave in addition to its supplemental Biologics License Application to constitute a "major amendment," triggering the three-month extension.
Roche's application was backed up by data from its IMpower 150 study, which showed the four-drug combination extended median overall survival over the three drugs without Tecentriq by just four and a half months.
While that benefit was significant, it doesn't appear to clear the high bar set by Keytruda plus chemotherapy in the same first-line metastatic NSCLC setting. Roche appears to be focusing on the benefit its Tecentriq combination showed in patients with liver metastases or those with EGFR or ALK mutations, who are not cleared to receive Keytruda initially.
Now, though, it will have to wait another quarter before it can mount its challenge to Merck in the first-line NSCLC setting.
Three other Phase 3 studies testing different combinations with Tecentriq in non-squamous and squamous NSCLC have also read out positive, although an overall survival benefit has not yet been observed in two.
Instead, it may be in small cell lung cancer — representing about 15% of all lung cancers — where Roche can steal first-mover advantage over Merck. There, a trial in June showed Tecentriq plus chemo hit on both progression-free survival and overall survival for previously untreated patients.
Tecentriq sales have grown steadily, and a first-line approval would be an unquestioned commercial boost. But Roche's drug still widely trails Keytruda and Bristol-Myers Squibb's Opdivo (nivolumab) in total sales. Over the first six months of the year, Tecentriq brought in about $330 million versus $3.1 billion for Keytruda and a similar sum for Opdivo.
For its part, Bristol-Myers Squibb is awaiting a decision on first-line NSCLC use for Opdivo in patients with higher scores of a biomarker known as tumor mutation burden. The FDA is expected to issue a verdict on approval by Feb. 20, 2019.
- BioPharma Dive Roche's momentum grows as Tecentriq combo delivers survival benefit
- BioPharma Dive Merck raises the bar in lung cancer with Keytruda data
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