On June 1, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, reported that the clinical data of IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) monotherapy and combo-therapy with bevacizumab in advanced colorectal cancer were orally presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 1, 2025, View Source [SID1234653564]). IBI363 demonstrated encouraging response and overall survival benefit in the context of colorectal cancer, which is typically considered an immunologically ‘cold’ tumor, supports its unique mechanism of actions (MoA) of turning "cold tumor" into "hot tumor".

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Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year’s ASCO (Free ASCO Whitepaper) meeting, IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug’s novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited.

PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 monotherapy and combined with bevacizumab in participants with advanced colorectal cancer: results from Phase 1 studies

Two Phase 1 studies (NCT05460767, NCT06717880) were conducted to evaluate the safety, tolerability and preliminary efficacy of IBI363 monotherapy and combined with bevacizumab in patients with advanced colorectal cancer.

IBI363 monotherapy has demonstrated breakthrough antitumor therapeutic potential, showing a significant extension of overall survival compared to data of standard-of-care therapies

As of the data cutoff date (Apr 7th, 2025), a total of 68 participants with advanced colorectal cancer received IBI363 monotherapy at the dose levels from 0.1 mg/kg to 3mg/kg. No patients were confirmed as microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR). 86.8% of patients were microsatellite stable (MSS) or proficient mismatch repair (pMMR). 61.8% of patients had liver metastases. 63.2% of patients had previously received 3 or more lines of systemic anti-tumor treatments. 23.9% of patients had received prior immunotherapy.
Notably, among patients receiving monotherapy with IBI363 (n=68), with a median follow-up time of 20.1 months, the median overall survival (OS) reached 16.1 months, demonstrating a significant improvement compared to the historical data of standard treatments (ranging from 6.4 to 9.3 months1-3).
Subgroup analyses revealed that patients with or without liver metastasis both showed excellent overall survival (OS), indicating significant clinical benefit. The median OS were 14.4 months (with liver metastasis) and 17.0 months (without liver metastasis).
Among patients treated with monotherapy of IBI363 1 mg/kg every 2 weeks (Q2W) (n=22), the confirmed objective response rate (cORR) was 13.6%.

Liver metastasis
(n = 42)

without liver metastasis
(n = 26)

Total

(n = 68)

Median OS, month (95% CI)

14.4 (8.0, 18.8)

17.0 (9.9, NC)

16.1 (10.1, 18.8)

6-month OS rate, % (95% CI)

81.3 (64.6, 90.6)

80.0 (58.4, 91.1)

80.7 (68.5, 88.6)

12-month OS rate, % (95% CI)

54.8 (36.9, 69.5)

59.5 (37.8, 75.8)

56.6 (43.0, 68.1)

18-month OS rate, % (95% CI)

37.6 (21.3, 53.9)

44.8 (24.0, 63.6)

40.3 (27.2, 53.0)

OS median follow-up time, month (95% CI)

20.2 (17.9, 20.7)

20.1 (16.8, 21.7)

20.1 (17.7, 20.6)

The combination of IBI363 and bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile, with excellent data on objective response rate and progression-free survival

As of the data cutoff date (Apr 7th, 2025), a total of 73 patients with advanced colorectal cancer received IBI363 （dose levels from 0.6 mg/kg to 3mg/kg） and bevacizumab combination therapy. No patients were confirmed as MSI-H or dMMR. 91.8% of patients were MSS or pMMR. 56.2% of patients had liver metastases. 54.8% of patients had previously received 3 or more lines of systemic anti-tumor treatments. 16.4% of patients had received prior immunotherapy.
In all participants treated with IBI363 in combination with bevacizumab (n=73), the cORR was 15.1% and the disease control rate (DCR) was 61.6%. With a median follow-up time of 9.9 months, the median progression free survival (PFS) reached 4.7 months. With a median follow-up time of 9.4 months, OS was not mature, with events in only 13 participants (17.8%).
As for the combination therapy in patients without liver metastases (n=32), the confirmed ORR was 31.3%, with a DCR of 81.3%. The median PFS reached to 7.4 months.
In those participants who received IBI363 at 3 mg/kg Q3W plus bevacizumab (n=31), confirmed ORR and DCR increased to 19.4% and 71.0%, respectively. The median PFS increased to 5.6 months.

IBI363 3 mg/kg Q3W +Bevacizumab

(n = 31)

Without liver metastasis
(n = 32）

Total

(n = 73)

Confirmed ORR, % (95% CI)

19.4 (7.5, 37.5)

31.3 (16.1, 50.0)

15.1 (7.8, 25.4)

DCR, % (95% CI)

71.0 (52.0, 85.8)

81.3 (63.6, 92.8)

61.6 (49.5, 72.8)

Median PFS, month (95% CI)

5.6 (2.5,6.8)

7.4 (4.1, 9.8)

4.7 (2.5,6.7)

PFS median follow-up time, month (95% CI)

8.6 (7.2, 10.2)

9.9 (7.2, 13.1)

9.9 (7.2, 13.9)

In terms of safety, among participants receiving monotherapy and combination therapy, 19 (27.9%) and 26 (35.6%) reported treatment-related adverse events (TRAEs) of Grade 3 or higher, respectively. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. No new safety signals were observed, with a manageable risk-benefit profile in IBI363 alone or in combination with bevacizumab.
Tumor immune cell infiltration analysis supports the IBI363 MOA of turning "cold tumor" into "hot tumor", demonstrating enrichment of PD1+CD25+CD8+ cells in baseline tumor tissue association with clinical efficacy

In baseline tumor tissues, elevated infiltration of CD8+ cells, CD25+CD8+ cells, and PD1+CD25+CD8+ cells were associated with improved clinical response to IBI363 monotherapy (partial response or stable disease). This supports the potential anti-tumor effects of IBI363 in the treatment of colorectal cancer from the perspective of its mechanism of action.
Professor Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated: "Colorectal cancer is the third most common cancer type globally and ranks fourth in cancer-related mortality4. About 86% of colorectal cancer are in an immune ‘desert’ or immune-inflamed suppressed state, rendering traditional immune checkpoint inhibitors (ICIs) ineffective5. For colorectal cancer that has failed standard treatments, there are limited therapeutic options with short survival periods, representing a significant unmet clinical need6. IBI363, as a PD-1/IL-2α-bias bispecific fusion protein, has demonstrated robust antitumor efficacy in preclinical studies through the effective expansion of tumor-specific CD8⁺ T cells (TST cells). Its ability to block PD-1 and stimulate TST cells holds the potential to transform ‘cold’ tumors into ‘hot’ tumors. As a monotherapy, IBI363 achieves a median survival of 16.1 months in later-line treatments, which represents a significant improvement compared to the median survival of current standard therapies and also confirms its potential with a strong ‘tail effect’ as a PD1 plus cytokine bispecific immunotherapy. The combination of IBI363 with bevacizumab is still under continuous follow-up, having shown promising efficacy and tolerable safety, with unique efficacy characteristics particularly in the subgroup without liver metastasis. Overall, clinical data suggest that IBI363 combined with bevacizumab holds significant promise for colorectal cancer and warrants further exploration."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "On top of the preliminary data reported at 2024 ASCO (Free ASCO Whitepaper) and 2024 ESMO (Free ESMO Whitepaper), we are presenting more updated follow-up data and combination therapy results of IBI363 at the ASCO (Free ASCO Whitepaper) Congress this year. From a comprehensive body of clinical evidence that includes ORR, PFS, OS, IBI363 demonstrated robust antitumor activity of both monotherapy and combination therapy in patients with advanced colorectal cancer who are non-MSI-H/dMMR. We are eyeing on long-term survival data from high dose in longer follow-up period. And the pivotal study of IBI363 targeting advanced CRC is in plan. Observing such results in the context of colorectal cancer, which is typically considered an immunologically ‘cold’ tumor, further highlights the broad development potential of IBI363. It offers hope for expanding into areas where immunotherapy has been less effective or even unresponsive."

About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein)

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models.

In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy.

IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively.

On June 1, 2025 J INTS BIO, a company specializing in the development of therapeutics for cancer and rare diseases, reported interim results from the global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 (ASCO 2025), the world’s largest oncology conference, held in Chicago, USA (Press release, J INTS BIO, JUN 1, 2025, View Source [SID1234653563]).

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JIN-A02 is an oral, fourth-generation EGFR-TKI designed to overcome resistance mutations (such as C797S) that develop after treatment failure with third-generation EGFR-TKIs, which are currently the first-line therapy for EGFR-mutant Non-small cell lung cancer (NSCLC). It is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries. Key efficacy and safety results from Part A (dose escalation) of the multi-center clinical trial (NCT05394831) were presented.

‘Confirmed’ clinical response observed in patients with disease progression after 3rd Generation EGFR TKI and chemotherapy

One of the key findings of the ASCO (Free ASCO Whitepaper) presentation was that tumor responses were sustained in specific dose cohorts, with confirmed partial responses (PRs) verified by independent evaluation. Confirmed PRs were observed in 50mg,100mg and 300mg QD dose groups, providing clinical evidence of anti-tumor activity.

In the 50 mg dose group, patients achieved a 77.3% reduction in tumor size, maintaining a PR over six consecutive treatment cycles (from cycle 3 to cycle 13). In the 300 mg dose group, a confirmed PR was observed with a 39.7% tumor size reduction, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable, further supporting the potential of JIN-A02 in treating brain metastases.

Safety confirmed up to 300 mg, with therapeutic signals in brain metastases

No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which is six times the dose level when PR was first observed, demonstrating a favorable safety profile even at higher dose levels. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included for the first time, Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity, supporting the drug’s excellent safety profile. This safety and tolerability have translated into extended treatment durations in real-world settings, with a patient still on JIN-A02 after one year and seven months.

In addition, the trial demonstrated notable responses in brain metastases first noted at 100mg, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue.

JIN-A02 gains national spotlight as government grants accelerate development

In addition to the ASCO (Free ASCO Whitepaper) announcement, J INTS BIO continues to achieve noteworthy results in Korea. Recently, it was selected for the ‘2025 Baby Unicorn Fostering Project’ by the Ministry of SMEs and Startups, officially recognizing both our scientific technology and commercialization potential. The ‘Baby Unicorn Fostering Project’ is a government project that focuses on developing promising startups with innovative technologies and growth potential in the global market as ‘potential unicorns’. Companies selected for this project will receive full government support in recognition of their technological prowess and growth potential.

With these accolades, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years, which is expected to be a decisive point to significantly accelerate the pace of clinical and commercialization in parallel with private investment. It is also significant as a case of securing confidence in the 3 arena of technology, marketability, and global scalability, as the recognition came from different government departments.

Based on these achievements, we plan to initiate the Phase 2 clinical trial of JIN-A02 in before the end of this year, in discussions with the US FDA.

"The ASCO (Free ASCO Whitepaper) presentation of JIN-A02’s ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance," said Dr. Anna Jo, CEO. "The government’s continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization"

On June 2, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first site activation within Australia, as part of the investigator sponsored Phase II Neo-POLEM clinical trial (Press release, Imugene, JUN 2, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0af44840-0a27-5641-dade-e0642353307d/1st_Australian_site_activated_PD1_Vaxx_Neo_POLEM_Ph_II_trial.pdf [SID1234653561]).

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Neo-POLEM is a Phase II study investigating the potential of PD1-Vaxx, a neoadjuvant PD-1 vaccine, to improve treatment outcomes for patients with mismatch repair-deficient / microsatellite instability high (dMMR/MSI-high) colorectal cancer. Approximately 15% of patients with colorectal cancer have the dMMR/MSI-high subtype.

The trial is an IST being conducted by Cancer Research UK Southampton Clinical Trials Unit in collaboration with Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trial Group (AGITG).

The primary objective of the study is to determine major pathological response rates, a measure of tumour size reduction post-treatment with PD1-Vaxx before surgery, with secondary objectives to assess the safety of PD1-Vaxx, evaluate biomarkers, and evaluate the objective response rates and overall survival.

This trial builds upon compelling early evidence that immunotherapy can deliver significant benefits in this patient population. The trial will recruit patients in both Australia and the United Kingdom.

Imugene’s CEO and Managing Director Leslie Chong said: "We’re very pleased to see this Neo-POLEM IST open and enrolling in Australia. PD1-Vaxx has the potential to offer a durable immune response and improve treatment outcomes, and we look forward to further progress in both Australia and the UK."

Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer, with a worldwide annual incidence of more than 1.2 million cases and a mortality rate of approximately 50%. About 80% of patients with colon cancer have localised and resectable disease at diagnosis. Approximately 15% of CRC is dMMR/MSI-high.

On June 1, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported to have presented new positive data on TG4050 in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Transgene, JUN 1, 2025, View Source [SID1234653559]).

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These positive data confirm that individualized neoantigen therapeutic vaccine TG4050 is safe and feasible in the adjuvant setting of resectable HPV-negative locally advanced head and neck squamous cell carcinoma (HNSCC). TG4050 induces, as monotherapy, long-lasting immune responses to vaccine neoantigens sustained for up to 2 years, and these results met all trial endpoints (NCT04183166) including safety, feasibility, immune activation and disease-free survival (defined as survival without recurrence or death for any cause).

TG4050 is based on Transgene’s myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection.

Positive data from Phase I, confirming proof of principle
of Transgene’s viral vector based individualized cancer vaccine TG4050
in HPV-negative locally advanced head and neck cancer

100% disease free survival at a minimum of 2-year follow-up of treated patients (median follow-up: 30 months) in the Phase I part of the trial: all patients in the TG4050 treatment arm remain disease free while 3 patients in the observational arm have relapsed.
Persistence of neoantigen-specific CD8+ T cell responses over 2 years after the start of TG4050 has been observed.
Dr. Alessandro Riva, CEO of Transgene, commented: "The sustained clinical and immunogenicity outcomes observed over two years of TG4050 monotherapy, along with the positive safety profile, mark an important milestone for Transgene. These results reinforce both the clinical promise of TG4050 and our commitment to accelerate the development of this individualized immunotherapy in adjuvant setting for patients with HPV-negative, locally advanced head and neck cancer."

Motoo Nishihara, Corporate EVP, and CTO, at NEC, commented: "This positive readout, combined with the durability of the efficacy data at two years, underscore the clinical potential of individualized cancer vaccine programs. It is a strong validation of our innovative AI platform and our dedication to advancing solutions that deliver meaningful, long-term value to patients and healthcare systems alike."

Ongoing Phase II part of Phase I/II clinical trial of individualized neoantigen therapeutic cancer vaccine TG4050

TG4050 is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Based on the promising data obtained in the Phase I part of the trial, Transgene and NEC extended the joint development of TG4050 in this indication with a Phase II extension of the trial.

The Phase II part of the trial, aimed at confirming the encouraging results in a larger patient population and evaluating both immunological and clinical outcomes, is currently underway. All patients are expected to be randomized by Q4 2025. Altogether, the Phase I/II study will comprise approximately 80 patients.

Dr Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology), will discuss the data presented at ASCO (Free ASCO Whitepaper) 2025, the unmet medical need and current treatment landscape for patients suffering from head and neck cancers in a live virtual event taking place on June 6, 2025 (9:00 p.m. ET; 3:00 p.m. CET).

On June 1, 2025 Novartis reported data from a new subgroup analysis of the Phase III NATALEE trial evaluating the efficacy and safety of Kisqali (ribociclib) plus endocrine therapy (ET, a non-steroidal aromatase inhibitor) in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence across age and menopausal status (Press release, Novartis, JUN 1, 2025, View Source [SID1234653558]). The data will be presented today at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Results at median follow-up of 44.2 months show that patients receiving Kisqali continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status1. In this one-year post-treatment analysis, pre-menopausal and younger patients, who often present with more aggressive disease characteristics, experienced greater reductions in risk of recurrence and fewer treatment discontinuations due to adverse events (AEs) than post-menopausal patients1.

"As the incidence of early onset breast cancer increases, it is encouraging to see that ribociclib continues to deliver durable risk reduction for a broad population of patients with EBC, including younger patients," said Dr. Kevin Kalinsky, Division Director of Medical Oncology and Director of the Glenn Family Breast Center at Winship Cancer Institute of Emory University. "Coupled with the lower rates of discontinuation due to AEs seen in this subgroup, these data reinforce the benefit of three-year adjuvant treatment with ribociclib as a well-tolerated intervention for patients seeking to reduce the likelihood of their cancer coming back."

Pre-menopausal patients
(n = 2238) Post-menopausal patients
(n = 2844)
Hazard ratioa
(95% CI) All
Kisqali = 1115
ET = 1123 All
Kisqali = 1424
ET = 1420
Invasive disease-free survival
(iDFS) 0.671
(0.518-0.870) 0.746
(0.607-0.917)
Distant disease-free survival
(DDFS) 0.655
(0.498-0.861) 0.759
(0.612-0.941)
Recurrence-free survival
(RFS) 0.641
(0.486-0.845) 0.735
(0.588-0.919)
Disposition in Kisqali arm, n (%)
Discontinuation due to AE 179 (16.1) 326 (22.9)
Dose reduction due to AE 248 (22.4) 332 (23.6)
a Hazard ratios between treatment arms (RIB + NSAI; NSAI alone), stratified by stage, prior chemotherapy, and geographic region.

Addressing Recurrence in Other At-Risk Groups
A separate real-world analysis of EBC patients who met the NATALEE trial eligibility criteria and received ET monotherapy found that Black patients were more likely to be younger, pre-menopausal, have stage III tumors, and have more extensive nodal involvement than white patients. After adjusting for these factors, Black patients also had worse RFS, DDFS, and overall survival than their white counterparts. These findings reinforce the critical need to improve care for Black patients with the addition of a CDK4/6 inhibitor to their adjuvant treatment3.

Novartis is continuing to add to the body of evidence on the efficacy and safety of Kisqali in different patient populations. Trial design details will be presented at ASCO (Free ASCO Whitepaper) for the Adjuvant WIDER study, which is enrolling patients that closely reflect the population seen in clinical practice, including more patients from racial and ethnic minority groups4.

"There is an undeniable and urgent need to improve outcomes for vulnerable patient populations, including younger and Black patients, who often face more aggressive forms of breast cancer and remain at high risk of recurrence," said Reshema Kemps-Polanco, Executive Vice President and Chief Commercial Officer, Novartis US. "With Kisqali, we have the opportunity to reduce the risk of recurrence for these patients with early breast cancer, while we continue to offer significant survival benefit to patients living with metastatic disease."

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO5,6. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable5,6. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria5,6. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial5,6.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Kisqali has been approved as a treatment for breast cancer by regulatory authorities in 99 countries worldwide, including the U.S. FDA and the European Commission7,8. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET7. In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence; and for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression8. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist7,8.

In EBC, ribociclib (Kisqali) is the only CDK4/6 inhibitor recommended by the NCCN Guidelines for breast cancer for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 39. Kisqali approvals in EBC from regulatory authorities worldwide are ongoing, including recent approval from China’s National Medical Products Administration10. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials11-21. The NCCN Guidelines also recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- MBC when combined with an AI9, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC.

In addition, Kisqali has achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC22; and has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer23. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line24.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com