* SKYSCRAPER-06 evaluating tiragolumab plus Tecentriq and chemotherapy did not

    meet the primary endpoints of progression-free survival at primary analysis
    and overall survival at first interim analysis
  * The combination of tiragolumab plus Tecentriq and chemotherapy showed
    reduced efficacy compared to the comparator arm
  * Safety was consistent with previous studies, however we intend to halt the
    trial due to reduced efficacy compared to the comparator arm

Basel, 04 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that
the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq(®)
(atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an
initial (first-line) treatment for people with previously untreated, locally
advanced unresectable or metastatic non-squamous non-small cell lung cancer, did
not meet its primary endpoints of progression-free survival (PFS) at its primary
analysis with a hazard ratio (HR) of 1.27 (95% CI: 1.02,1.57) and overall
survival (OS) at its first interim analysis with a HR of 1.33 (95% CI:
1.02, 1.73), which was immature. The combination of tiragolumab plus Tecentriq
and chemotherapy showed reduced efficacy in both PFS and OS compared to the
comparator arm in the intent-to-treat population, which includes the phase II
and phase III cohorts. The overall safety profile remains consistent with the
safety profile previously observed for the combination of tiragolumab plus
Tecentriq and chemotherapy, and no new or unexpected findings were identified.
Based on these results, patients and investigators will be unblinded and we
intend to halt the study. A communication will be sent to the investigators and
results will be shared with health authorities and subsequently presented at an
upcoming medical meeting.
"These results are disappointing as it was our hope that this combination might
yield improved outcomes for people living with metastatic non-squamous lung
cancer," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of
Global Product Development. "We are thankful to all of the patients and
healthcare professionals involved in the study, and we will leverage the
learnings to inform our scientific understanding of the anti-TIGIT pathway and
new avenues in cancer research."
Ongoing phase III studies are investigating treatment settings and indications
distinct from SKYSCRAPER-06. Based on today's results, we will evaluate any
relevant changes needed to the ongoing tiragolumab programme.
About SKYSCRAPER-06 study
SKYSCRAPER-06 is a global phase II/III, randomised, placebo-controlled and
double-blinded study evaluating tiragolumab plus Tecentriq(®) (atezolizumab) and
chemotherapy as an initial (first-line) treatment versus pembrolizumab and
chemotherapy in 542 people with non-squamous non- small cell lung cancer.
Primary endpoints are overall survival (OS) and progression-free survival (PFS).
About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor with an
intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory
immune checkpoint which suppresses the immune response to cancer. Based on
preclinical research, tiragolumab is thought to work as an immune amplifier with
other cancer immunotherapies such as Tecentriq® (atezolizumab). The TIGIT
pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade
with tiragolumab and Tecentriq may help overcome immune suppression and restore
the immune response.
About Tecentriq(®) (atezolizumab)
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and
difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy
approved for the treatment of a certain type of early-stage (adjuvant) non-small
cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular
carcinoma (HCC). Tecentriq is also approved in countries around the world,
either alone or in combination with targeted therapies and/or chemotherapies,
for various forms of metastatic NSCLC, certain types of metastatic urothelial
cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC),
BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma
(ASPS).
Tecentriq is a monoclonal antibody designed to bind with a protein called
programmed death ligand-1 (PD-L1), which is expressed on tumour cells and
tumour-infiltrating immune cells, blocking its interactions with both PD-1 and
B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-
cells. Tecentriq is a cancer immunotherapy that has the potential to be used as
a foundational combination partner with other immunotherapies, targeted
therapies and various chemotherapies across a broad range of cancers.
In addition to intravenous infusion, Tecentriq has been approved as a
subcutaneous formulation in over 40 countries. The approved indications for
Tecentriq SC mirror those of Tecentriq IV.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial
manufacturers of branded medicines, Roche has grown into the world's largest
biotechnology company and the global leader in in-vitro diagnostics. The company
pursues scientific excellence to discover and develop medicines and diagnostics
for improving and saving the lives of people around the world. We are a pioneer
in personalised healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care for each
person we partner with many stakeholders and combine our strengths in
Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do,
Roche has been named one of the most sustainable companies in the
pharmaceuticals industry by the Dow Jones Sustainability Indices for the
fifteenth consecutive year. This distinction also reflects our efforts to
improve access to healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the Roche Group.
Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com (http://www.roche.com).
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