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Roche Posts Positive Phase II Results on Immunotherapy Combo

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Roche (RHHBY - Free Report) announced positive results from a mid-stage study, CITYSCAPE, on immunotherapy, tiragolumab, and PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab).

CITYSCAPE is a global phase II, randomized and blinded study, evaluating the tiragolumabin combination with Tecentriq compared with Tecentriq alone in 135 patients with first-line PD-L1-positive, locally-advanced unresectable or metastatic non-small cell lung cancer (NSCLC).

Tiragolumab is a novel cancer immunotherapy designed to bind to TIGIT, an immune checkpoint protein expressed on immune cells.

Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit.

Results from the primary analysis showed that the combination met both co-primary endpoints in the intention-to-treat (ITT) population, showing an improvement in the objective response rate (ORR) (31.3% vs 16.2%). The combination also resulted in a 43% reduction in the risk of disease worsening or death (progression-free survival or PFS).

In addition, an exploratory analysis in patients with high levels of PD-L1 (TPS ≥50%) showed a clinically meaningful improvement in ORR and a 67% reduction in the risk of disease worsening or death with the combination compared with Tecentriq alone.

Further, the analysis suggested that the combination of tiragolumab plus Tecentriq was well tolerated and resulted in similar rates of all Grade 3 or more all-cause adverse events (AEs) when combining the two immunotherapies compared with Tecentriq alone (41.8% vs 44.1%).

The improvement in the ORR and PFS in the tiragolumab plus Tecentriq arm was maintained in both the ITT and the PD-L1-high populations at a six-month follow-up and no new safety signals were observed.

The full results will be presented in an oral abstract session at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO).

We note that Roche has already initiated two phase III studies evaluating tiragolumab plus Tecentriq in people with certain types of lung cancer (SKYSCRAPER-01 and SKYSCRAPER-02). Tiragolumab is also being evaluated in other solid tumors as well as hematological cancers. Additional phase 1Ia/b results in solid tumors will be presented at an upcoming medical meeting.

We remind investors that Tecentriq is already approved in the United States, the EU and other countries either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

Roche’s stock has gained 10.9% in the year so far against the industry’s decline of 1.3%.



A potential approval of the combination will broaden Roche’s immunotherapy portfolio in the wake of stiff competition from Merck’s (MRK - Free Report) Keytruda and Bristol-Myers’ (BMY - Free Report) Opdivo. Other PD-L1 inhibitors available in the market include AstraZeneca’s (AZN - Free Report) Imfinzi.

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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