Roche's Tecentriq Gives Lung Cancer Patients More Disease-Free Time

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Roche’s checkpoint inhibitor Tecentriq (atezolizumab) hit the mark in the company’s Phase III IMpower010 trial of the drug compared to best supportive care (BSC) in people with resectable early-stage lung cancer. The primary endpoint was disease-free survival (DFS) at the interim analysis.

The drug showed a statistically significant improvement in DFS as adjuvant therapy after surgery and chemotherapy in all randomized Stage II-IIIA populations with non-small cell lung cancer (NSCLC). There was a pronounced benefit in the PD-L1-positive population.

The company plans to continue analyses of DFS in the overall intent-to-treat (ITT) population. At the time of analysis, this didn’t cross the threshold. They also plan to follow overall survival (OS) data, which was immature at the time of analysis.

“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, Roche’s chief medical officer and head of Global Product Development. “We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population. We will submit these data to regulatory authorities as soon as possible.”

Tecentriq is approved in the U.S., European Union and other countries, either as a monotherapy or in combination with targeted therapies or chemotherapies in several forms of NSCLC, SCLC, certain forms of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the U.S., it is approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for treatment of BRAF V600 mutation-positive advanced melanoma.

The drug is being evaluated in multiple ongoing and planned Phase III trials in a broad range of lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.

Merck’s checkpoint inhibitor Keytruda (pembrolizumab) is the standard-of-care for newly diagnosed NSCLC, although it did not demonstrate the same benefit in SCLC. SCLC is not as common as NSCLC, but is usually more aggressive, growing faster and metastasizing earlier. The five-year survival rate with SCLC is as low as 6%, with about two-thirds of patients diagnosed with advanced disease.

In January, Roche received Breakthrough Therapy Designation (BTD) from the FDA for a combination of Tecentriq and its investigational TIGIT blocker tiragolumab as first-line treatment of certain metastatic NSCLC patients. This was in patients whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. Tiragolumab was the first anti-TGIT drug to be granted BTD by the FDA. That designation was based on data from the Phase II CITYSCAPE clinical trial.

“We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer,” Garraway said in January. “We look forward to advancing our tiragolumab development program, which includes chemotherapy-free combinations and trials in early stages of disease across multiple cancer types with high unmet need.”

TIGIT and PD-L1 both play a role in suppression of the immune system. Blocking both pathways can potentially increase anti-tumor activity by improving the body’s immune response to cancer cells.

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