- The Food and Drug Administration approved the use of Roche's immuno-oncology drug Tecentriq in combination with chemotherapy in previously untreated lung cancer. Tecentriq was already approved in that setting, but only when used with a second Roche drug called Avastin as part of a four-drug regimen.
- Tecentriq is one of four immuno-oncology agents vying to unseat Merck & Co.'s Keytruda as the biggest selling immune-stimulating oncology drug in non-small cell lung cancer. It is the only one besides Keytruda so far that has won a first-line approval, and the removal of Avastin should make it more attractive for patients and physicians.
- Keytruda had sales of $7.2 billion in 2018, while Tecentriq brought in 772 million Swiss francs ($781 million) over that same time period.
Keytruda (pembrolizumab) may be the top seller in non-small cell lung cancer thanks to its prized position as the first to gain FDA approval in a chemotherapy combination to treat never-before-treated patients. But Merck's competitors are not going to let it hold that position without competition.
Tecentriq's (atezolizumab) approval last December as part of a combination with Avastin (bevacizumab) and chemo was a step forward, but the use of two branded biologics makes it an expensive pairing that also adds some side effect risks.
The new approval allows Tecentriq to be used with two chemo agents called Abraxane (paclitaxel) and carboplatin, the same two chemotherapy drugs used in the four-drug combination.
FDA relied on data from the IMpower 130 study, which found that patients taking the Tecentriq-based combination on average lived significantly longer than patients taking only the chemotherapy — 18.6 months versus 13.9 months. Tecentriq patients also went longer without their disease worsening, lasting on average 7.2 months versus 6.5 months.
The patients in IMpower 130 had a type of lung cancer called non-squamous non-small cell disease that had spread to other parts of the body.
A comparative study for Keytruda was Keynote-189, which tested it in combination with pemetrexed and platinum-based chemotherapy. Patients in the Keytruda arm lived 22 months compared with 10.7 months for those in the chemo-only group, and lasted nine months without their disease worsening compared with 4.9 months for those on chemo alone.
In Keynote-189, Keytruda reduced the risk of death by 44%, compared with the 20% reduction for Tecentriq in IMpower 130.
The other two drugs approved in lung cancer in this class of drugs, called PD-1/L1 blockers, are Bristol-Myers Squibb's Opdivo (nivolumab) and AstraZeneca's Imfinzi (durvalumab). Both have reported positive data in first-line lung cancer in recent months, although in combination with chemotherapy and agents in another class called CTLA-4 inhibitors, which have substantial side effects.
The approval should allow Tecentriq to vault ahead of Opdivo to take second place in non-small cell lung cancer sales in 2020, according to analysts from Cowen. Yet that lead might not last long, as Cowen predicts Opdivo will reclaim its advantage by 2022.
Merck will hold first place in the disease, with a forecast $8.6 billion in 2020 and $10 billion in 2021, Cowen said.