Genentech Seeks FDA’s Blessings after Adjuvant Tecentriq Shows Promising Result in Lung Cancer Patients

In its latest attempt to outshine Merck’s Keytruda, Genentech, a Roche subsidiary says it has interim Phase 3 data to back Tecentriq as an adjuvant therapy in patients with non-small cell lung cancer (NSCLC).

Genentech says its checkpoint inhibitor and PD-1 blockbuster Tecentriq is helping lung cancer patients keep cancer from returning after surgery alongside chemotherapy longer than standard treatment alone. Although the details from the Phase 3 IMpower 010 study are still under wraps, the company claims that the drug works better at keeping off cancer in patients whose tumors are positive for PD-L1 protein. “With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.

Tecentriq: A Blockbuster Checkpoint Inhibitor

Genentech’s Tecentriq is a checkpoint inhibitor anti-cancer therapy that targets PD-L1 receptor protein expressed on the surface of many tumor cells. Inhibiting the interaction between PD-1 antigen and its receptor PD-L1 has been shown to boost the immune system to attack tumor cells. Other checkpoint inhibitors such as Merck’s Keytruda and BMS’s opdivo work differently than Tecentriq and target PD-1 antigen to prevent cancer- promoting interaction. Tecentriq has previously shown clinically meaningful benefits in various types of lung cancers and was the first approved immunotherapy for the front-line treatment of small cell lung cancer. After its success in the front-line, Genentech is testing Tecentriq’s efficacy in various other cancer indications and different settings, including the adjuvant setting.

IMPower010 Study

The study evaluated a group of 1,005 patients whose cancer was mostly localized to the lungs and had undergone surgery followed by up to four cycles of chemotherapy to treat cancer. Half of the patients in the group received Tecentriq plus chemotherapy and the other half received chemotherapy only. The interim analysis of the study showed that the drug was effective at extending the amount of time patients with lung cancers survived without any signs or symptoms of the disease. However, the final data is not out yet.

The study will continue evaluating DFS in the overall intent-to-treat population, which “at the time of analysis did not cross the threshold.” Additionally, they would analyze the overall survival data, which “were immature at the time of interim analysis.” Details about the study will be presented at an upcoming medical meeting and submitted to regulatory authorities for review.

Checkpoint Inhibitors as Adjuvant Therapies

After looking at the success of checkpoint therapies at later stages, many companies are testing these therapies in earlier stages of cancer for example after cancer surgery with the belief that it may disrupt the course of the disease, reduce recurrence and lead to better outcomes for patients. Merck & Co. started testing its drug blockbuster Keytruda in an adjuvant setting and bagged its first approval in 2019 as an adjuvant treatment of Stage 3 melanoma. Looking at the success in the melanoma setting, Merck expanded adjuvant Keytruda’s testing in other cancer indications. However, early this year it faced a huge setback when the FDA slapdown its pitch for accelerated approval for adjuvant Keytruda in triple-negative breast cancer indication.

At the same time, BMS presented positive news for Opdivo in the urothelial cancer adjuvant setting. The company reported early this year that Opdivo reduced the risk of disease recurrence by 47% and doubled the average length of time patients lived without disease recurrence.

If adjuvant Tecentriq gets FDA approval for lung cancer treatment, it may give a tough fight to other checkpoint inhibitors being tested in the adjuvant setting.

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Ruchi Jhonsa