Roche Holding ( RHHBY Quick Quote RHHBY - Free Report) accidentally disclosed results from its second interim analysis of the late-stage SKYSCRAPER-01 study.This phase III study is evaluating tiragolumab in combination with Tecentriq (atezolizumab) compared with Tecentriq alone as a first-line treatment for patients with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC). Roche’s tiragolumab is an investigational anti-TIGIT immunotherapy that suppresses the immune response to cancer.
Roche reported that the second interim analysis took place in February 2023 and was based on a data cut-off in November 2022, with a median follow-up of 15.5 months.
Tecentriq, an anti-Pd-L1- monoclonal antibody (mAb), is the company’s leading immuno-oncology drug for multiple indications. Tecentriq is approved in the European Union and United States for previously treated metastatic NSCLC and certain types of untreated or previously treated metastatic urothelial carcinoma.
The global phase III SKYSCRAPER-01 has enrolled 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic NSCLC. The patient population was equally divided into two arms receiving either the tiragolumab/Tecentriq combo or placebo and Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. The study’s co-primary endpoints are overall survival (OS) and progression-free survival in the tiragolumab/Tecentriq set.
Per the data readout, the interim results for the primary endpoint of OS were not mature at the time of the second interim analysis. It was observed that the median OS for the tiragolumab/Tecentriq combo arm was estimated at 22.9 months, while that in the Tecentriq monotherapy arm was 16.7 months. The difference in the OS in the two arms yielded a hazard ratio of 0.81.
Additionally, the tiragolumab/Tecentriq combo regime was overall well-tolerated by the patients and no new safety signals were observed.
The SKYSCRAPER-01 study is currently ongoing and will be continued until the final analysis for OS, per Roche. The company also intends to continue all other studies in the tiragolumab program as planned.
Shares of Roche jumped 4.33% on Aug 23, 2023, in response to the positive results. Year to date, shares of RHHBY have lost 4.7% against the
industry’s 7.6% rise. Image Source: Zacks Investment Research
It is also important to note that the successful nature of this innovative mechanism of action sparked a rise in the stock prices of smaller biotechnology companies, that are currently working on similar cancer immunotherapies, like
Iteos Therapeutics ( ITOS Quick Quote ITOS - Free Report) and Arcus Biosciences ( RCUS Quick Quote RCUS - Free Report) .
Iteos is developing EOS-448 in partnership with GSK for several cancer indications in separate studies, including metastatic NSCLC. EOS-448 is Iteos’ anti-TIGIT IgG1 antibody. ITOS is currently gearing up to initiate its phase III registrational studies evaluating EOS-448 in combination with GSK’s Jemperli (dostarlimab).
Arcus is also working on its portfolio of combination immunotherapies. It is currently conducting several mid-late-stage studies, in partnership with Gilead Sciences, on the combination therapy of domvanalimab and zimberelimab for several cancer indications, including NSCLC. Domvanalimab is the company’s anti-TIGIT mAb, while zimberelimab is its anti-PD-1 mAb.
In its second-quarter earnings release, Arcus shared upbeat initial data from its ongoing phase II ARC-7 study, which the company presented at a medical conference. Per the data readout, both domvanalimab-containing arms in the ARC-7 study witnessed consistent and clinically meaningful improvements in progression-free survival compared with zimberelimab monotherapy.
Currently, the standard of care in the frontline treatment of metastatic NSCLC is
Merck’s ( MRK Quick Quote MRK - Free Report) Keytruda. Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally. Zacks Rank
Roche currently has a Zacks Rank #3 (Hold).
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the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.