Adjuvant HR+/HER2- early BC - Novartis
See the ESMO 2026 6-Year OS Update →Posts by physicians about NATALEE during ESMO 2026 week (October 17–24, 2026), shown in full and verbatim, newest first, and linked to the originals on X. Several ask whether the OS result is formally significant; others weigh the size of the absolute gain.
𝕏NATALEE 6-year follow up is the best example of the mess that results in the Frequentist framework both in terms of multiplicity, and testing for any effect, even trivial 🧵 https://t.co/0Y587qAU0D
𝕏#NATALEE at 6 years: sustained iDFS benefit with adjuvant ribociclib. iDFS: 83.2% vs 77.9%. OS favored ribociclib; nominal significance only, with descriptive analysis outside formal testing. Assoc. Prof. Nurullah İlhan #ESMO2026 #BreastCancer #OncoTwitter https://t.co/ghHUlehacF
𝕏NATALEE | ESMO 2026 3 Years of Ribociclib. Is the Survival Benefit Finally Emerging? 🔹 6-year OS: 91.86% vs 89.73% HR 0.809 | Nominal P = 0.019 Absolute gain: +2.1% 🔹 6-year iDFS: 83.23% vs 77.92% HR 0.741 | Absolute gain: +5.3% 🔹 iDFS benefit increased from +4.1% at 5 years to +5.3% at 6 years, despite a median 38 months off ribociclib. TAKE-HOME: Sustained iDFS benefit with an encouraging OS signal. Formal OS statistical significance requires confirmation. Ref: Slamon DJ, Hortobagyi GN, et al. NATALEE 6-year OS and efficacy outcomes. ESMO 2026. #MVOnco #ESMO2026 #NATALEE #BreastCancer
𝕏#ESMO26 NATALEE 6-y OS results are online, ahead of today's presentation (2:25 pm). OS HR 0.809 (95% CI 0.661–0.989); 6-y OS: 91.9% vs 89.7% (Δ2.1%). Nominal 1-sided P=.019. What remains key? 👉 Post-protocol care! See why in my talk at @MDAnderson_ES 👇 https://t.co/ilGjsTQl3s
𝕏Today at #ESMO26, the 6-year results of NATALEE will be presented. Ahead of the presentation, my personal view on the survival gains with adjuvant CDK4/6 inhibitors… The 6-year OS rates in NATALEE were 91.86% vs 89.73%: an absolute gain of 2.1 percentage points (HR 0.809; 95% CI 0.661–0.989; nominal one-sided p=0.019). The absolute 7-year OS gain in monarchE was 1.8 percentage points (HR 0.842; p=0.027). I do not think these gains should be dismissed as “only 2%.” In the EBCTCG analysis, adding taxanes to anthracycline-based chemotherapy—an approach we have accepted as standard for years—provided an absolute 5-year OS gain of approximately 1.9 percentage points. The populations and follow-up periods differ, so we cannot directly compare treatment efficacy. However, the standards we use to judge a few percentage points of survival benefit should be consistent. Moreover, 95.4% of patients in monarchE had already received chemotherapy. This survival gain represents an additional benefit on top of chemotherapy and endocrine therapy. Patient selection, toxicity, treatment duration, and cost certainly deserve discussion. However, the survival benefit of adjuvant CDK4/6 inhibitors in appropriately selected patients should not be underestimated.
𝕏Not ready to call NATALEE an OS win. The p=.019 is one sided and nominal, on the 5th look at survival. More than twice as many control pts dropped out right after randomization, and post-relapse CDK4/6i use in the control arm hasn't been reported . https://t.co/ZfOdph2e93
𝕏NATALEE OS: no formal significance; the analysis is descriptive (nominal P, no alpha). monarchE, by contrast, had a prespecified alpha-controlled OS analysis and met it. NATALEE: HR ~0.80 stable, Δ2.1%, BCSS supportive. Clinically meaningful, not confirmatory. #ESMO26 #NATALEE #MonarchE
𝕏#ESMO26 | NATALEE – 6-year results (Pre-presentation abstract) 6-year OS: 92.73% vs 89.38% (HR 0.809; nominal p=0.019). iDFS: HR 0.741; absolute benefit of 4.1% at 6 years. In monarchE, a 7-year OS benefit was demonstrated (HR 0.842; p=0.027). NATALEE also shows a promising OS signal; however, formal statistical significance has not yet been established. Looking forward to the presentation....
𝕏can u suggest me a good magnifying glass ? Asking for a friend 😀 @myESMO #esmo26 As expected, no one talks about nominal p value. https://t.co/aGWpPg4U4M
𝕏Looks like the discussant is on my side too, Amol! 😉 We acknowledge the limitations of the nominal p-value, but I think it would be unfair to judge ribociclib’s clinical benefit solely on that basis. https://t.co/gQtuwasEEp https://t.co/absCmwDmqD
𝕏NATALEE: OS data Adjuvant ribociclib in ER+ breast cancer 6 yr OS HR 0.809 (delta 2.1%) BCSS: 0.706 (delta 2.6%) 6 yr iDFS HR 0.741 (delta ~5%) DDFS: HR 0.744 @OncoAlert #ESMO26
𝕏Great news! NATALEE is positive for overall survival. Great presentation from Dr Slamon. Big thanks to all the patients, and research nurses who risked themselves during COVID to make this study a success. #ESMO26 #ESMO2026 https://t.co/eqTqJ8Mg83
𝕏#NATALEE OS is here. HR 0.81, 178 vs 205 deaths, 6-year OS difference 2.1%. monarchE was HR 0.84, 1.8% at 7 years. Two CDK4/6 inhibitors, two schedules, strikingly similar survival effect. The OS gap widens after ribociclib stops at year 3, as expected since deaths lag relapses. More importantly, the iDFS curve is still separating after treatment ended. And control patients who relapsed could get a CDK4/6i for metastatic disease, which should shrink the OS difference. The benefit held. What NATALEE adds over monarchE is N0, about 12% of the trial. The iDFS signal is there. N0 OS will be underpowered for a long time, so that conversation in clinic stays an iDFS conversation. #bcsm #ESMO26
𝕏We as the oncology community need to think hard if the 2 % OS benefit in Natalee is worth the financial cost esp outside US Herizon data looks great and should be SOC https://t.co/gdQI5jMQmn
𝕏One of the most awaited abstracts of #ESMO26: OS results of the NataLEE trial Adjuvant ribociclib provides statistically significant ⬆️ OS: delta of 1.2% at 60 months and 2.1% at 72 months (6-years) Confirmed and sustained benefit in IDFS, DDFS and DRFS @OncoAlert https://t.co/XMjNQqwtJH
𝕏#ESMO26. The start to an exciting meeting - first two oral BC sessions today. The first session with OS data from Natalee, long term benefit from extended letrozole in B42, huge benefits from 3 novel ADCs in HER2 low/HR+ & Talent. @OncoAlert https://t.co/NsYeBeQYPH
𝕏1. NATALEE: Adj #Ribociclib in HR+ early breast cancer (Stg IIA - III), 400mg daily (3wks on, 1wk off) for 3yrs. - 6yr OS 91.9% vs 89.7, 2.1% absolute OS - HR: 0.809 - AEs: QTc prolongation, Neutropenia. 2/8 https://t.co/W0vqAprD7m https://t.co/2LVGfDDH5L
𝕏Two percentage points is small. We accepted it for taxanes, sure, but that doesn't make it the right bar. NATALEE's OS p-value is nominal, and we don't know how many controls got a CDK4/6i at relapse (in monarchE only 47% got one in 1L), so some of this could be CDK4/6i vs none rather than early vs late. Also open-label, and 7.9% of controls withdrew consent at randomization vs 3.3% on ribo.
𝕏🧬 NATALEE | 6-Year Update 3 years of ribociclib. 6 years of impact? 6 facts that may surprise you! 👀 📌 iDFS benefit widens: +4.1% → +5.3% 📌 OS signal emerges: HR 0.809 — but no alpha allocated! 📌 Benefit persists after a median 38 months off ribociclib. What about breast cancer-specific survival, the Asian subgroup, treatment completion and subsequent CDK4/6 inhibitor use? One cartoon. Two infographics. Six insights. The numbers are encouraging. The nuances matter. Slamon et al. | Annals of Oncology, 2026 #ESMO26 #NATALEE #BreastCancer #Ribociclib #MVOnco @myESMO @OncoAlert
𝕏NATALEE: 6-Year Update at #ESMO26 Adjuvant ribociclib + NSAI continues to improve iDFS in HR+/HER2− early breast cancer, with updated data showing an OS benefit (HR 0.81; 95% CI, 0.66–0.99) and improved #BreastCancer –specific survival. @OncoAlert #bcsm @myESMO https://t.co/MUiDWRxCjG
𝕏NATALEE 6-year OS analysis shows modest (early…given what we just saw in NSABP42…) improvement in OS. IDFS benefit persists over time. #ESMO26 @OncoAlert https://t.co/sNIIKpV3aG
𝕏6-year results of Natalee (ribociclib): improvements in OS, BCSS, iDFS, DRFS - some subgroups analyses still required #ESMO26 #ESMOAmbassadors #ESMOcommunity @myESMO @Annals_Oncology https://t.co/acLnDZoxka
𝕏#ESMO26 Natalee 6 year data with improvement in OS including in node negative & no prior chemo patients - with online publication in @Annals_Oncology #bcsm #ESMOAmbassadors @OncoAlert https://t.co/ABh6KQBC7R
𝕏Encouraging 6-year #NATALEE results presented at #ESMO26 ! 🎯 Adjuvant ribociclib + NSAI shows a deepening iDFS benefit and favourable OS results in HR+/HER2− early #BreastCancer @OncoAlert https://t.co/h5qTnzff5L
𝕏🚨 ESMO 2026 | NATALEE: Positive OS at 6 yrs! 🔹 OS: HR 0.809 (95% CI 0.661–0.989), P=0.019 🔹 6-yr OS: 91.9% vs 89.7% (Δ 2.1%) 🔹 BCSS: HR 0.706 (~29% ↓ BC mortality) 🔹 iDFS/DDFS/DRFS: ~5% absolute benefit at 6 yrs 🔹 OS benefit generally consistent across subgroups 🔹 Post-recurrence CDK4/6i: 21% vs 44.4% Take-home: First positive OS results from NATALEE, supporting adjuvant RIB in HR+/HER2− EBC. #ESMO26 #NATALEE #BreastCancer #bcsm @OncoAlert
𝕏The updated NATALIE trial shows sustained and deepening of the DFS after longer follow up. At this point the absolute gain in OS is 2.1% #ESMO2026 @E_de_Azambuja @matteolambe @myESMO @BarbaraPistill2 @jhaveri_komal https://t.co/dtxlJFKGo0
𝕏I see the benefit in high-risk, node-positive patients, especially after the NSABP B-42 data presented at #ESMO26. However, I have more doubts about the N0 population in NATALEE. Great topic!@Rodrosb
𝕏#ESMO26 | NATALEE: 6-year outcomes Adjuvant ribociclib + NSAI vs NSAI alone in eligible HR+/HER2− stage II–III EBC: ▪️ OS HR 0.809 (95% CI 0.661–0.989) Absolute 6-year benefit: 2.1 percentage points ▪️ IDFS HR 0.741 (95% CI 0.646–0.849) Absolute 6-year benefit: 5.3 percentage points Benefit persists with patients off ribociclib for a median of ~3 years. 𝘔𝘺 𝘬𝘦𝘺 𝘲𝘶𝘦𝘴𝘵𝘪𝘰𝘯: 𝘐𝘯 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭𝘭𝘺 𝘦𝘭𝘪𝘨𝘪𝘣𝘭𝘦 𝘱𝘢𝘵𝘪𝘦𝘯𝘵𝘴 𝘸𝘪𝘵𝘩 𝘭𝘰𝘸 𝘖𝘯𝘤𝘰𝘵𝘺𝘱𝘦 𝘋𝘟 𝘙𝘚 𝘢𝘯𝘥/𝘰𝘳 𝘭𝘰𝘸 𝘰𝘷𝘦𝘳𝘢𝘭𝘭 𝘳𝘦𝘤𝘶𝘳𝘳𝘦𝘯𝘤𝘦 𝘳𝘪𝘴𝘬, 𝘦𝘴𝘱𝘦𝘤𝘪𝘢𝘭𝘭𝘺 𝘕0 𝘥𝘪𝘴𝘦𝘢𝘴𝘦, 𝘪𝘴 𝘵𝘩𝘦 𝘢𝘣𝘴𝘰𝘭𝘶𝘵𝘦 𝘣𝘦𝘯𝘦𝘧𝘪𝘵 𝘭𝘢𝘳𝘨𝘦 𝘦𝘯𝘰𝘶𝘨𝘩 𝘵𝘰 𝘫𝘶𝘴𝘵𝘪𝘧𝘺 3 𝘺𝘦𝘢𝘳𝘴 𝘰𝘧 𝘳𝘪𝘣𝘰𝘤𝘪𝘤𝘭𝘪𝘣, 𝘤𝘰𝘯𝘴𝘪𝘥𝘦𝘳𝘪𝘯𝘨 𝘵𝘰𝘹𝘪𝘤𝘪𝘵𝘺, 𝘮𝘰𝘯𝘪𝘵𝘰𝘳𝘪𝘯𝘨 𝘣𝘶𝘳𝘥𝘦𝘯, 𝘢𝘯𝘥 𝘘𝘖𝘓? #BreastCancer #NATALEE
𝕏Cowabunga! 🌊 Riding the Early & Adjuvant Breast Cancer Wave 🏄🏻♂️🤙🏻 from #ESMO26 NATALEE, 6 yrs: ribociclib overall survival hazard ratio 0.81, +2.1%. Encouraging, concordant, consistent. But: no alpha, nominal p, fragility ~2–3 deaths. @OncoDaily #OncoDailyAmbassador @OncoAlert
𝕏NATALEE at 6 years: Ribociclib + NSAI vs NSAI alone in HR+/HER2− early breast cancer: • 6-year OS: 91.86% vs 89.73% • OS HR 0.809 (95% CI 0.661–0.989); nominal 1-sided P=0.019 • Absolute OS benefit: 2.1% • 6-year iDFS: 83.23% vs 77.92% • iDFS HR 0.741 (95% CI 0.646–0.849) • Absolute iDFS benefit: 5.3% Is OS significant? Looking forward to full data .@Timothee_MD @myESMO @OncBrothers @OncoAlert #ESMO26 #BreastCancer #NATALEE
𝕏Six years into NATALEE, the key question is no longer whether adjuvant ribociclib improves iDFS. Does the benefit remain durable-and is an OS signal emerging? LBA25 at #ESMO26, led by Dennis J. Slamon, with investigators @KalinskyKevin @LoiSher. What would change your practice most: absolute iDFS gain, OS maturity, or long-term treatment burden? #bcsm
𝕏#ESMO26 tomorrow the 6-y survival results of the NATALEE trial will be presented in Madrid, 2:25 pm trial = 3 years adjuvant ribociclib in patients with HR+ HER2- early breast cancer. what will be key? 👉 Post-protocol data see why in my talk today at @MDAnderson_ES! https://t.co/L2GO43fOYR
The ESMO 2026 LBA25 abstract (Slamon et al.) reports a prespecified analysis of overall survival and efficacy with 6 years of follow-up. At the data cutoff (15 May 2026), all patients were off ribociclib for a median of 38 months. Dennis J. Slamon presents it in the Proffered Paper session on Friday, October 23, 2026, 14:25–14:35.
From the abstract — ribociclib 400 mg/day (3 weeks on, 1 week off, for 3 years) + NSAI vs NSAI alone, high-risk stage II–III HR+/HER2− early breast cancer:
Earlier OS readouts on this page come from earlier data cuts and are separate analyses: HR 0.89 (95% CI 0.66–1.20) at the final iDFS analysis, and HR 0.800 (95% CI 0.637–1.003; nominal one-sided p=0.026) at the 5-year analysis presented at ESMO 2025. Some posts on X quoted 6-year figures that differ from the abstract; the values above are taken from the abstract text.
Sources: ESMO 2026 LBA25 abstract · ClinicalTrials.gov NCT03701334
At the final iDFS analysis (median follow-up 33.3 months), ribociclib plus ET demonstrated a significant iDFS benefit with HR 0.749 (95% CI: 0.628-0.892; p=0.0006). The 3-year iDFS rates were 90.7% versus 87.6%, a 3.1% absolute benefit. At the 4-year landmark analysis (44.2 months median follow-up), the benefit was sustained with HR 0.715 (95% CI: 0.609-0.840; p<0.0001). At the 5-year analysis (58.4 months median follow-up), HR was 0.716 (95% CI: 0.618-0.829; nominal p<0.0001), with 5-year iDFS rates of 85.5% versus 81.0%, representing a 4.5% absolute improvement and a 28.4% reduction in risk of recurrence sustained approximately 2 years after completing ribociclib treatment.
At the final iDFS analysis, there were 84 deaths (3%) on the ribociclib arm and 88 deaths (3%) on the ET-alone arm, with an OS HR of 0.89 (95% CI: 0.66-1.20). At the 5-year analysis, the OS trend favored ribociclib with HR 0.800 (95% CI: 0.637-1.003; nominal 1-sided p=0.026), but the trial was not powered for OS. At the 6-year analysis (ESMO 2026 LBA25 abstract, DCO 15-May-2026, median OS follow-up 66.5 months), 6-year OS was 91.86% vs 89.73% (HR 0.809; 95% CI 0.661–0.989; nominal one-sided P=.019) and breast cancer–specific survival HR was 0.706 (95% CI 0.559–0.890).
The 400 mg dose showed a predictable and manageable safety profile. Grade 3+ neutropenia occurred in 44.3% but rarely led to clinical complications (febrile neutropenia 0.3%, no neutropenia deaths). Hepatotoxicity occurred in 26.4% (grade 3+: 8.6%), with DILI in 0.4% including 8 Hy's Law cases, all resolving after discontinuation. QTc prolongation was infrequent at 5.3% all-grade (grade 3+: 1.0%), with no Torsades de Pointes. Treatment discontinuation due to AEs was 19.5%, primarily from elevated transaminases (ALT 7.1%) occurring early (median ~4 months). Dose interruptions occurred in 86.1% and dose reductions in 26.7%, primarily for neutropenia. Median relative dose intensity was 94.0%.
Regulatory status & clinical implications — FDA approved Sept 17, 2024 for adjuvant HR+/HER2- stage II-III EBC at high risk, with an AI. (FDA.gov) NATALEE established adjuvant ribociclib as the standard of care for the broadest population of HR+/HER2- early breast cancer patients at risk of recurrence, including those with node-negative disease. The 5-year data showing sustained benefit approximately 2 years after completing 3 years of treatment supports a durable biological effect. Key clinical debates include the optimal selection between ribociclib (NATALEE) and abemaciclib (monarchE) given their different patient populations and dosing strategies, the 3-year treatment duration versus the 2-year duration used with abemaciclib, and whether the lower 400 mg dose adequately balances efficacy and tolerability for long-term adjuvant use.
Sponsor / Drug — Novartis; ribociclib (Kisqali), an oral CDK4/6 inhibitor, 400 mg 3-weeks-on/1-off for 36 months. (FDA label)
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated October 24, 2026.
Presented by Dennis J. Slamon, MD, PhD (LBA25, Proffered Paper Session, Oct 23, 2026), with discussant Fumikata Hara, as shared by physicians. Each slide appears once, from the physician post with the widest reach. The 6-year results are descriptive (nominal P values). Click any image to enlarge.
| Arm | N | OS events | 60-mo OS | 72-mo OS |
|---|---|---|---|---|
| Ribociclib + NSAI | 2549 | 178 | 93.9% | 91.9% |
| NSAI alone | 2552 | 205 | 92.7% | 89.7% |
| Difference 1.2% at 60 mo and 2.1% at 72 mo (slide footnote: does not equal 2.2 due to rounding). HR 0.809 (95% CI 0.661–0.989); nominal P=0.019, one-sided, descriptive. | ||||
Source: ESMO 2026 LBA25 slide (Dennis J. Slamon), as shared on X by Yakup Ergün, Oct 23, 2026. Medians not reached.
| Arm | N | BCSS events | 60-mo BCSS | 72-mo BCSS |
|---|---|---|---|---|
| Ribociclib + NSAI | 2549 | 126 | 95.5% | 94.2% |
| NSAI alone | 2552 | 166 | 94.0% | 91.6% |
| Difference 1.5% at 60 mo and 2.6% at 72 mo. HR 0.706 (95% CI 0.559–0.890); nominal P=.002, one-sided. | ||||
Source: ESMO 2026 LBA25 slide (Dennis J. Slamon), as shared on X by Yakup Ergün, Oct 23, 2026.
| Arm | N | iDFS events | 60-mo iDFS | 72-mo iDFS |
|---|---|---|---|---|
| Ribociclib + NSAI | 2549 | 374 | 85.3% | 83.2% |
| NSAI alone | 2552 | 461 | 81.2% | 77.9% |
| Difference 4.1% at 60 mo and 5.3% at 72 mo. HR 0.741 (95% CI 0.646–0.849); nominal P<.0001, one-sided. | ||||
Source: ESMO 2026 LBA25 slide (Dennis J. Slamon), as shared on X by Paolo Tarantino, Oct 23, 2026.
| Endpoint | Arm (n=2549 / 2552) | Events | 60 mo | 72 mo |
|---|---|---|---|---|
| DDFS | Ribociclib + NSAI | 344 | 86.5% | 84.5% |
| DDFS | NSAI alone | 423 | 82.8% | 79.6% |
| DRFS | Ribociclib + NSAI | 305 | 88.2% | 86.0% |
| DRFS | NSAI alone | 378 | 84.7% | 81.6% |
| DDFS: difference 3.7% at 60 mo and 4.9% at 72 mo; HR 0.744 (95% CI 0.646–0.858); nominal P<.001, one-sided. DRFS: difference 3.5% and 4.4%; HR 0.738 (95% CI 0.634–0.858); nominal P<.0001, one-sided. | ||||
Source: ESMO 2026 LBA25 slide (Dennis J. Slamon), as shared on X by Matteo Lambertini, Oct 23, 2026.
NATALEE is a global Phase III, multicenter, randomized, open-label trial that established adjuvant ribociclib (Kisqali) at 400 mg as the first CDK4/6 inhibitor approved for the broadest population of patients with HR+/HER2-negative stage II and III early breast cancer at high risk of recurrence. The trial randomized 5,101 patients across 20 countries to receive ribociclib plus a nonsteroidal aromatase inhibitor (letrozole or anastrozole) for 3 years with endocrine therapy for at least 5 years, or endocrine therapy alone. NATALEE uniquely included node-negative patients and used a lower 400 mg dose (versus the 600 mg metastatic dose) to optimize tolerability over the 3-year treatment duration.
Phase III, global, multicenter, randomized (1:1), open-label trial conducted at 393 centers across 20 countries in collaboration with TRIO. Stratified by menopausal status, AJCC 8th edition anatomic stage (II vs. III), prior neoadjuvant/adjuvant chemotherapy (yes vs. no), and geographic region.
Adults (men and pre- or postmenopausal women) with HR+/HER2-negative stage II or III early breast cancer at high risk of recurrence. Stage IIA T2N0 patients required grade 2 tumor with Ki-67 >=20% or high genomic risk (Oncotype DX Recurrence Score >=26, or high-risk by Prosigna/PAM50, MammaPrint, or EndoPredict), or grade 3 tumor. Node-positive disease of any stage II/III was eligible regardless of additional risk factors. Stage II comprised 40.3% and stage III comprised 59.4% of the study population.
Ribociclib 400 mg once daily (3 weeks on / 1 week off in 28-day cycles) for up to 36 months plus NSAI (letrozole or anastrozole) for at least 5 years, with goserelin for men and premenopausal women. Control arm received NSAI alone for at least 5 years.
Primary endpoint: invasive disease-free survival (iDFS) per STEEP criteria. Secondary endpoints: recurrence-free survival (RFS), distant disease-free survival (DDFS), overall survival (OS), patient-reported outcomes (PROs), safety/tolerability, and pharmacokinetics. Exploratory endpoints included locoregional recurrence-free survival and time to subsequent antineoplastic therapy.
Presented by Stephen K.L. Chia, MD (May 30, 2026 · Chicago) — PAM50 intrinsic subtype + gene-expression sub-analysis of 3,022 patients from the NATALEE adjuvant ribociclib + NSAI trial in HR+/HER2− early breast cancer.
Gene-expression signal (exploratory): higher genomic risk and proliferation scores trended toward larger ribociclib benefit; higher CEACAM6 and lower GATA3 / CDK4 expression were associated with greater iDFS gain. None reached statistical significance for treatment interaction.
KOL takeaway — Paolo Tarantino, MD: "Interesting PAM50 sub-analysis from NATALEE, presented by Stephen Chia, showing a clear prognostic, but not predictive, role for PAM50 subtypes. Benefit from adjuvant ribociclib observed across subtypes and risk scores, with larger delta in HER2-E and basal-like tumors." [source →]
Live ASCO 2026 coverage → · Source: ASCO 2026 Abstract 501 (Chia et al., n=3,022 PAM50)
Posts from the ASCO 2026 period and earlier (previously listed as this page’s Top 12 by impressions), shown in full and verbatim, newest first.
Prognostic and predictive impact of baseline gene expression in the NATALEE trial of adjuvant ribociclib + nonsteroidal aromatase inhibitor in HR+/HER2− early #BreastCancer Stephen K.L. Chia #ASCO26 @OncoAlert #OncoAlert https://t.co/irIGGXNUGx
NATALEE試験において、結局、アジュバントでのRibociclibはPAM50によるサブタイプに関わらず上乗せ効果あり。 誰にでも同じぐらい効いていたとも言えるけど、いまいちいいバイオマーカーが出てこないからやらなくていい集団がいまいち見つからないCDK4/6阻害薬… #ASCO26 https://t.co/SNsmeOcYl9
NATALEE Biomarker Analysis #ASCO26 Ribociclib + NSAI demonstrated consistent iDFS benefit across all PAM50 intrinsic subtypes in HR+/HER2− early breast cancer — regardless of luminal A, luminal B, HER2-enriched, or basal-like classification (interaction P=.34). iDFS HR: 0.71
Benefit of #ribociclib in #NATALEE: - persists across intrinsic subtypes - is greater in pts with higher risk tumors - may be variable based on certain gene expression ( ⬆️ benefit CEACAM6, ⬇️ CDK4, GATA3 etc) #ASCO26 #bcsm https://t.co/7BlAYcA46M
リボシクリプの術後内分泌療法への追加を見たNATALEE試験のバイオマーカー別サブ解析 内因性サブタイプがluminalより他のタイプの方が差が大きく見えたり、アグレッシブな遺伝子変化のほうが大きな利益は興味深い アベマシクリブも似た話になりそう #ASCO26 https://t.co/CJo6VbLIF6
NATALEE Trial: Consistent iDFS Benefit with Ribociclib Across All PAM50 Intrinsic Subtypes in HR+/HER2− Early #BreastCancer @OncoAlert @ASCO #ASCO26 #bcsm https://t.co/Xa11SvqEDs
New biomarker insights from NATALEE trial presented by Stephen Chia, MD 📊 Baseline gene expression shows prognostic & predictive impact in HR+/HER2- early #breastcancer treated with adjuvant ribociclib + aromatase inhibitor #ASCO26 @ASCO https://t.co/iCG3ubX768
NATALEE gene-expression analysis presented #asco26 Ribociclib benefit seen across all PAM50 intrinsic subtypes Trend toward greater benefit for higher genomic risk or proliferation signatures Expression of several gene associated with increased ribociclib benefit @OncoAlert h
#ASCO26 🧬 Not all HR+/HER2- early breast cancers behave the same. New biomarker analysis from NATALEE suggests adjuvant ribociclib benefits were seen across ALL PAM50 subtypes, with a possible trend toward greater benefit in genomically higher-risk disease. 📌 3022 tumor https:/
💫🌟🚨 Top 10 #BreastCancer abstracts for #ASCO26 — selected by our leads and finalized via a Delphi voting process 🗳️🔬 1️⃣ 500 — OPTIMA 2️⃣ LBA1006 — PERSEVERA BC 3️⃣ 507 — KEYNOTE-522 final analysis 4️⃣ LBA1007 — SERENA-6 5️⃣ 502 — LIDERA BC 6️⃣ LBA1000 — ASCENT-04 7️⃣ 501 — NATA
If you can fit a laser pointer between the curves, you can give the #ASCO24 plenary! https://t.co/TrmXCzrp3J
NATALEE (NCT03701334) is a Phase 3 trial of 3 years of adjuvant ribociclib (Kisqali) 400 mg plus a nonsteroidal aromatase inhibitor versus endocrine therapy alone in 5,101 adults with HR-positive/HER2-negative stage II–III early breast cancer, including higher-risk node-negative disease. See Trial Design.
Yes. On September 17, 2024 the FDA approved Kisqali (ribociclib) with an aromatase inhibitor for the adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence; a ribociclib + letrozole co-pack was also approved. See At a Glance.
Ribociclib plus endocrine therapy significantly improved invasive disease-free survival (HR 0.749 at the final iDFS analysis), with the benefit sustained at later landmarks. The 6-year analysis (ESMO 2026 LBA25 abstract) also reports overall survival, with a nominal P-value. All figures, sources and data cuts: At a Glance.
NATALEE enrolled a broader population, including some higher-risk node-negative patients, and used ribociclib 400 mg for 3 years; monarchE (abemaciclib) was limited to node-positive high-risk disease. See Trial Design.
Ribociclib (Kisqali) is a CDK4/6 inhibitor developed by Novartis.
Want the aggregated read across all of this drug's trials? See Physician sentiment on KISQALI® (ribociclib) — KOL Pulse's breakdown of oncologist opinion on ribociclib, the CDK4/6 inhibitor studied in NATALEE.
