Novartis’ Kisqali (ribociclib) has been proven to reduce the risk of recurrence in early breast cancer, according to the results of the Phase III NATALEE study. This groundbreaking news was announced by the company on Monday, and is sure to be a major boon for those affected by the disease.
The remarkable combination of Kisqali and endocrine therapy has been demonstrated to enhance invasive disease-free survival (iDFS) in patients with HR+/HER2- disease, outperforming standard adjuvant endocrine therapy alone. This remarkable result has been achieved without the need to reveal specific data, indicating the potential of this powerful combination.
The NATALEE study was so successful that an Independent Data Monitoring Committee recommended ending the trial early. Following protocol, Novartis will continue to monitor the participants in order to evaluate their long-term outcomes, including overall survival. The outstanding results of the study have given hope to many patients and caregivers alike.
Monday saw Novartis’ stock skyrocket 6% in premarket trading, marking a significant surge for the company.
Despite endocrine therapy, up to 60% of women with HR+/HER2- early stage breast cancer remain at risk of recurrence. A company spokesperson recently revealed that approximately 30-60% of these patients are still at risk of the disease returning even after endocrine treatment has been administered.
The NATALEE Phase III trial has made a groundbreaking discovery, confirming the effectiveness of CDK4/6 inhibitor treatments for patients with breast cancer, regardless of whether they have nodal involvement or not. This marks an important milestone in the fight against the disease, offering a new hope for those affected.
The NATALEE study is a groundbreaking, international research project enrolling 5,100 adult patients from 20 countries. This randomized, open-label trial has the ambitious goal of achieving a greater understanding of the long-term impacts of breast cancer.
Its primary outcome measure is iDFS, a composite of locoregional relapse, ipsilateral and contralateral invasive breast cancer, distant recurrence, new types of cancer events, and death from any cause.
In this study, Kisqali was administered at a relatively low starting dose of 400 mg in order to minimize any potential negative impacts on patient quality of life, as opposed to its approved dosage of 600 mg for metastatic disease.
Novartis is taking a significant step forward in its commitment to improving healthcare by submitting data from its NATALEE program to regulatory bodies across the globe. With the submission of this data, Novartis is hopeful that the outcome of these discussions could have a positive impact on the healthcare industry.
Novartis’ Recent Cancer Developments
Novartis’ oncology portfolio has seen yet another major success with Kisqali’s late-stage triumph. This latest development is another step forward in the company’s mission to provide cutting-edge treatments for cancer patients around the world.
In December 2022, Novartis’ groundbreaking intravenous radioligand Pluvicto (lutetium (177Lu) vipivotide tetraxetan) made history by aceding the Phase III PSMAfore trial and achieving significant and clinically meaningful improvements in radiographic progression-free survival for metastatic castration-resistant prostate cancer (mCRPC) patients who tested positive for the prostate-specific membrane antigen (PSMA).
This remarkable breakthrough is sure to revolutionize the medical landscape and bring much needed hope to those suffering from mCRPC.
Pluvicto has already been approved for treating prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), offering new hope to patients suffering from this debilitating condition.
In August 2022, Novartis and BeiGene reported promising results from their Phase III RATIONALE 301 study. The investigational antibody tislelizumab showed a non-inferior overall survival rate compared to sorafenib in the treatment of unresectable hepatocellular carcinoma, a major breakthrough in the fight against this deadly cancer.
In November, Novartis announced disappointing results from the CANOPY-A trial, which were unable to demonstrate a benefit in improving disease-free survival (DFS) in adult non-small cell lung cancer patients using the candidate therapy canakinumab. This was a major setback for the company, as the potential of this promising drug had generated a lot of excitement.