Roche's Kadcyla is the first targeted therapy to show significant
overall survival benefit in people with HER2-positive early-stage
breast cancer with residual invasive disease after neoadjuvant
treatment
- Phase III KATHERINE results
reinforce Kadcyla as the standard of care for this population, with
more than 82,000 people treated to
date1,2
- Long-term data also showed
continued benefit in invasive disease-free survival for adjuvant
Kadcyla compared to Herceptin in this
study2
- These data will be
presented as an oral presentation at the 2023 San Antonio Breast
Cancer Symposium and included in the official press
programme
Basel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today positive long-term follow-up data from the pivotal,
phase III KATHERINE study in people with HER2-positive early-stage
breast cancer (eBC) who have residual invasive disease following
neoadjuvant (before surgery) treatment. A statistically significant
and clinically meaningful improvement in overall survival (OS), a
secondary endpoint, was observed with adjuvant (post-surgery)
Kadcyla® (trastuzumab emtansine) compared to Herceptin®
(trastuzumab): at the 7-year landmark OS rates were 89.07% and
84.37% with Kadcyla and Herceptin, respectively (hazard ratio
[HR]=0.66, 95% CI: (0.51, 0.87), p-value =0.0027).2 Data also show
that the previously reported invasive disease-free survival
(primary endpoint) benefit is maintained.2 Kadcyla reduced the risk
of disease recurrence or death from any cause by 46% compared to
Herceptin (HR=0.54, 95% CI: (0.44, 0.66), p-value <0.0001),
strengthening the results of the primary analysis of KATHERINE.2,3
The safety profile of Kadcyla was consistent with previous findings
and no new safety signals were identified.2
“We are pleased that Kadcyla could offer people with
HER2-positive early breast cancer with a particularly poor
prognosis a chance to live longer and without recurrence of their
disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “The ultimate goal
of treating early breast cancer is to maximise the chance of cure,
and these results signify an important step forward for these
patients.”
"Thanks to remarkable advances in diagnostics and treatment,
more women are surviving an initial diagnosis of HER2-positive
early-stage breast cancer than ever before. However, in those
with higher risk disease, recurrence and
long-term survival have remained a challenge,” said Prof. Dr.
Sibylle Loibl, Chair of the German Breast Group (GBG), Principal
Investigator of KATHERINE. “With these new data, Kadcyla
is the first targeted therapy to demonstrate a significant survival
benefit in people with HER2-positive early breast cancer with
residual invasive disease after neoadjuvant treatment."
The KATHERINE study has been conducted in collaboration with the
GBG and NSABP Foundation, Inc. Full data are being presented as an
oral presentation at the 2023 San Antonio Breast Cancer Symposium
on Friday 08 December.
Kadcyla is approved in 113 countries and is the standard of care
for people with HER2-positive eBC with residual invasive disease
following neoadjuvant treatment, based on previous positive results
from KATHERINE that showed Kadcyla cut the risk of disease
recurrence or death by half versus Herceptin.1,3 Additionally, at
three years, 88.3% of people treated with Kadcyla did not have
their breast cancer return compared to 77.0% treated with
Herceptin, an absolute improvement of 11.3%.3
Breast cancer is the most frequently diagnosed type of cancer,
with major societal impact.4 Approximately one in five people with
breast cancer will be HER2-positive, a particularly aggressive form
of the disease.5 The goal in treating eBC is to provide people with
the best chance for a cure.6 While we come closer to this goal with
each advance, many people still have disease recurrence in the
long-term and more personalised treatment options are needed to
reduce this risk and help people live longer.7,8
Kadcyla is also approved for the treatment of people with
HER2-positive metastatic breast cancer who previously received
trastuzumab and a taxane.
About the KATHERINE studyKATHERINE is an
international, multi-centre, two-arm, randomised, open-label, phase
III study evaluating the efficacy and safety of Kadcyla versus
Herceptin as an adjuvant therapy in people with HER2-positive
early-stage breast cancer who have residual invasive disease
following neoadjuvant therapy that included Herceptin and
taxane-based chemotherapy.9 In KATHERINE, residual invasive disease
was defined as the presence of invasive residual disease in tissue
samples from breast and/or axillary nodes following neoadjuvant
treatment.9 People who have residual invasive disease after
neoadjuvant treatment generally have a worse prognosis than those
without detectable disease at surgery.10
The primary endpoint of the study is invasive disease-free
survival (iDFS) which, in this study, is defined as the time from
randomisation free from invasive breast cancer recurrence or death
from any cause.9 Secondary endpoints include DFS and overall
survival.9
About KadcylaKadcyla is an antibody-drug
conjugate (ADC) engineered to deliver potent chemotherapy directly
to HER2-positive cancer cells, potentially limiting damage to
healthy tissues. It combines two anti-cancer properties joined
together by a stable linker: the HER2-targeting properties of
trastuzumab (the active ingredient in Herceptin) and the
chemotherapy agent DM1.11 Kadcyla is approved for the treatment of
people with HER2-positive metastatic breast cancer (as of 2013) and
HER2-positive early-stage breast cancer (as of 2019). Roche
licenses technology for Kadcyla under an agreement with ImmunoGen,
Inc.
About Roche’s medicines for HER2-positive breast
cancerRoche has been leading research into the HER2
pathway for over 30 years and is committed to improving the health,
quality of life and survival of people with both early-stage and
advanced HER2-positive disease. HER2-positive breast cancer is a
particularly aggressive form of the disease that affects
approximately 15-20% of patients.5
Roche has developed innovative medicines, including in
patient-centric formulations, which have helped transform the
treatment of HER2-positive breast cancer: Herceptin® (trastuzumab)
in both intravenous and subcutaneous formulations, Perjeta®
(pertuzumab), Kadcyla® (trastuzumab emtansine) and PHESGO®
(pertuzumab, trastuzumab, and hyaluronidase-zzxf).12,13,14
Eligibility for treatment with Roche’s HER2-targeted medicines is
determined via a diagnostic test, which identifies people who will
likely benefit from these medicines at the onset of their
disease.
About Roche in breast cancerRoche has been
advancing breast cancer research for more than 30 years with the
goal of helping as many people with the disease as possible. Our
medicines, along with companion diagnostic tests, have contributed
to bringing breakthrough innovations in HER2-positive and
triple-negative breast cancers. As our understanding of breast
cancer biology rapidly improves, we are working to identify new
biomarkers and approaches to treatment for all forms of early-stage
and advanced breast cancer, including triple-negative and hormone
receptor-positive.
Our targeted medicines Herceptin® (trastuzumab), Perjeta®
(pertuzumab), PHESGO® (pertuzumab, trastuzumab, and
hyaluronidase-zzxf), Kadcyla® (trastuzumab emtansine) and
Tecentriq® (atezolizumab) are continuing to transform the treatment
of early-stage and advanced HER2-positive and triple-negative
breast cancers and, through our clinical programmes, we hope to
bring new treatment combinations to people with breast cancer,
ultimately improving outcomes.12,13,14,15
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 thirteenth 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.
All trademarks used or mentioned in this release are protected
by law.References[1] Roche data on file. [2] Loibl
S, et al. Phase III study of adjuvant ado-trastuzumab emtansine vs
trastuzumab for residual invasive HER2-positive early breast cancer
after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE
final IDFS and updated OS analysis. Presented at: San Antonio
Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, Texas, USA.
Abstract #GS03-12.[3] von Minckwitz G, et al. Trastuzumab Emtansine
for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med.
2019;380:617-28.[4] Arnold M, et al. Current and future burden of
breast cancer: Global statistics for 2020 and 2040. Breast.
2022;66:15-23.[5] American Cancer Society. Breast cancer HER2
status [Internet; cited December 2023]. Available from:
https://www.cancer.org/cancer/types/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html.[6]
Scharl A, et al. The Right Treatment for the Right Patient -
Personalised Treatment of Breast Cancer. Geburtshilfe Frauenheilkd.
2015;75(7):683–91.[7] Jorge Dino Cossetti R, et al. Comparison of
breast cancer recurrence and outcome patterns between patients
treated in 1986-1992 and 2004-2008. Journal of Clinical Oncology.
2014;32(15):521. [8] Dieci MV, et al. Biomarkers for HER2-positive
metastatic breast cancer: Beyond hormone receptors. Cancer Treat
Rev. 2020;88:102064.[9] Clinical trials.gov. A Study of Trastuzumab
Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With
HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast
or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
[Internet; cited December 2023]. Available from:
https://clinicaltrials.gov/study/NCT01772472. [10] Cortazar P, et
al. Pathological complete response and long-term clinical benefit
in breast cancer: the CTNeoBC pooled analysis. Lancet.
2014;384(9938):164-72. [11] Verma S, et al. Trastuzumab Emtansine
for HER2-Positive Advanced Breast Cancer. N Engl J Med.
2012;367(19):1783-91.[12] National Comprehensive Cancer Network
(NCCN) Breast Cancer Guidelines – Version 4.2023 [Internet; cited
December 2023]. Available from:
https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.[13]
Denduluri N, et al. Selection of optimal adjuvant chemotherapy and
targeted therapy for early breast cancer: ASCO Guideline Update. J
Clin Oncol. 2021;39(6):685-93. [14] Swain S, et al. Targeting
HER2-positive breast cancer: advances and future directions. Nat
Rev Drug Discov. 2023;22:101-26.[15] Schmid P, et al. Atezolizumab
and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N
Engl J Med. 2018;379:2108-21.
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