Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2− Advanced Breast Cancer

Fasching, Peter A.; Delea, Thomas E.; Lu, Yen‐Shen; Boer, Richard de; Hurvitz, Sara A.; Moynahan, Aaron; Chandiwana, David; Lanoue, Brad; Thuerigen, A.; O’Shaughnessy, Joyce

doi:10.2147/cmar.s325043

Cited by 3 publications

(6 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The results of the current anchored MAIC analysis are also consistent with a prior unanchored MAIC analysis that compared PFS and OS with first-line ribociclib versus palbociclib, such that there was a numerical PFS benefit and significant OS benefit observed with ribociclib over palbociclib. 14 This previously published MAIC analysis used individual patient data from patients treated with first-line ribociclib + fulvestrant in the phase III MONALEESA-3 trial and palbociclib + letrozole in the phase II PALOMA-1 trial. 14 Although the analysis used a phase II trial (PALOMA-1) with a smaller sample size (and associated CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; HR, hazard ratio; ITT, intent to treat; LET, letrozole; ML-2, MONALEESA-2; OS, overall survival; PAL, palbociclib; PAL-2, PALOMA-2; PBO, placebo; RIB, ribociclib.…”

Section: Discussionmentioning

confidence: 99%

“…14 This previously published MAIC analysis used individual patient data from patients treated with first-line ribociclib + fulvestrant in the phase III MONALEESA-3 trial and palbociclib + letrozole in the phase II PALOMA-1 trial. 14 Although the analysis used a phase II trial (PALOMA-1) with a smaller sample size (and associated CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; HR, hazard ratio; ITT, intent to treat; LET, letrozole; ML-2, MONALEESA-2; OS, overall survival; PAL, palbociclib; PAL-2, PALOMA-2; PBO, placebo; RIB, ribociclib.…”

Section: Discussionmentioning

confidence: 99%

“…Taken together, the MAIC data presented here, along with data from prior MAIC and primary efficacy analyses, provide meaningful evidence that the CDK4/6is -in this case, ribociclib and palbociclib -are not the same. 7,8,14 Preclinical data have shown that ribociclib has greater CDK4 versus CDK6 inhibition; additionally, at clinically relevant doses, ribociclib has higher free drug concentrations than palbociclib. [22][23][24][25] Clinical data have shown significant OS benefit with ribociclib in prespecified final analyses of all three of its phase III clinical trials in HR+/HER2− ABC (MONALEESA-2: HR, 0.76; 95% CI, 0.63-0.93; p = 0.008; MONALEESA-3: HR, 0.72; 95% CI, 0.57-0.92; p = 0.005; MONALEESA-7: HR, 0.71; 95% CI, 0.54-0.95; p = 0.010).…”

Section: Therapeutic Advances In Medical Oncologymentioning

confidence: 99%

“…11 MAIC has been widely used to compare a range of outcomes from phase III clinical trials where no head-to-head study has been available, including among CDK4/6is. [12][13][14][15] In addition, MAIC has been accepted by several national health technology assessment agencies to help inform decision-making. 11,16 In this study, an MAIC was performed to compare both PFS and OS with first-line ribociclib + letrozole versus palbociclib + letrozole using data from the MONALEESA-2 and PALOMA-2 trials.…”

Section: Introductionmentioning

confidence: 99%

“…11 MAIC has been widely used to compare a range of outcomes from phase III clinical trials where no head-to-head study has been available, including among CDK4/6is. 12–15 In addition, MAIC has been accepted by several national health technology assessment agencies to help inform decision-making. 11,16…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

Jhaveri,

O’Shaughnessy,

Fasching

et al. 2023

Ther Adv Med Oncol

Self Cite

View full text Add to dashboard Cite

Background: Current standard-of-care first-line treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC) is cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + endocrine therapy. In the MONALEESA-2 trial, first-line ribociclib + letrozole demonstrated statistically significant overall survival (OS) benefit versus placebo + letrozole in postmenopausal patients with HR+/HER2− ABC. In the PALOMA-2 trial, first-line palbociclib + letrozole did not show OS benefit versus placebo + letrozole in a similar patient population. Understanding OS outcomes in the respective trials is critical for treatment decisions; however, there are no head-to-head clinical trial data comparing ribociclib and palbociclib. Objectives: To conduct a matching-adjusted indirect comparison (MAIC) to compare progression-free survival (PFS) and OS of first-line ribociclib + letrozole versus palbociclib + letrozole in postmenopausal patients with HR+/HER2− ABC. Design: Letrozole-anchored MAIC using individual patient data from MONALEESA-2 and published summary data from PALOMA-2. Methods: Using individual data, patients from MONALEESA-2 who matched inclusion criteria from PALOMA-2 were selected, and weighting was conducted to ensure baseline characteristics were similar to those in published aggregated data from PALOMA-2. The Bucher method was used to generate corresponding hazard ratios (HRs). Results: The final effective sample size compared n = 150 (ribociclib) and n = 112 (placebo) MONALEESA-2 patients with n = 444 (palbociclib) and n = 222 (placebo) PALOMA-2 patients. After matching and weighting, patient characteristics were well balanced. MAIC analysis showed a numerical PFS benefit [HR, 0.80; 95% confidence interval (CI), 0.58–1.11; p = 0.187] and significant OS benefit (HR, 0.68; 95% CI, 0.48–0.96; p = 0.031) with ribociclib + letrozole versus palbociclib + letrozole. Conclusion: Results of this cross-trial MAIC analysis showed a numerical PFS benefit and significantly greater OS benefit with first-line ribociclib + letrozole versus palbociclib + letrozole. These results support letrozole + ribociclib as the preferred first-line CDK4/6i for postmenopausal patients with HR+/HER2− ABC. Trial registration: NCT01958021; https://www.clinicaltrials.gov/study/NCT01958021 (MONALEESA-2) and NCT01740427; https://clinicaltrials.gov/study/NCT01740427 (PALOMA-2).

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Therapeutic Advances In Medical Oncologymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

Jhaveri,

O’Shaughnessy,

Fasching

et al. 2023

Ther Adv Med Oncol

Self Cite

View full text Add to dashboard Cite

show abstract

Head‐to‐head comparison of palbociclib and ribociclib in first‐line treatment of HR‐positive/HER2‐negative metastatic breast cancer with real‐world data from the OPAL registry

Thill,

Zahn,

Welt

et al. 2024

Intl Journal of Cancer

View full text Add to dashboard Cite

Cyclin‐dependent kinase 4/6 inhibitors (CDKIs) in combination with endocrine therapy (ET) are the standard‐of‐care in the first‐line treatment of HR‐positive, HER2‐negative metastatic breast cancer. In the absence of direct head‐to‐head trials comparing the efficacy and safety of the different CDKIs, the individual choice of treatment in everyday practice is complex. Inverse probability of treatment weighting was used to emulate a head‐to‐head comparison of palbociclib +ET (PALBO) and ribociclib +ET (RIBO) in patients recruited into the prospective, observational, multicenter registry platform OPAL (NCT03417115). Progression‐free survival (PFS), overall survival (OS) and quality of life surveys were analyzed, also for subgroups stratified by treatment‐free interval (TFI). A total of 623 patients with HR‐positive, HER2‐negative metastatic breast cancer received PALBO (n = 388) or RIBO (n = 235) in their first line of treatment. No difference between PALBO and RIBO was found for PFS (median 26.7 months [23.6, 30.7] vs. 27.0 months [21.1, 30.4], HR 1.01 [0.80, 1.27]) and OS (median 42.4 months [38.8, 50.3] vs. 49.3 months [36.9, NA], HR 0.96 [0.71, 1.28]). There was a trend for longer PFS and OS in patients with TFI <12 months receiving RIBO. Patients reported comparable side effects for both CDKIs. This head‐to‐head comparison revealed no difference in PFS and OS between PALBO and RIBO, however, a trend to longer PFS and OS with RIBO was observed in the subgroup of patients with TFI <12 months. Side effects experienced with PALBO and RIBO highlight the important toxicities to be addressed during treatment decision.

show abstract

Cost-benefit evaluation of advanced therapy lines in metastatic triple-negative breast cancer in Germany

Wickmann,

Kurte,

Jeck

et al. 2024

Cost Eff Resour Alloc

View full text Add to dashboard Cite

Background Triple-negative breast cancer (TNBC) is responsible for 10–20% cases of breast cancer and is resulting in rising healthcare costs. Thus, health-economic evaluations are needed to relate clinical outcomes and costs of treatment options and to provide recommendations of action from a health-economic perspective. Methods We investigated the cost-benefit-ratio of approved treatment options in metastatic TNBC in Germany by applying the efficiency frontier approach. These included sacituzumab-govitecan (SG), eribulin, vinorelbine, and capecitabine. Clinical benefit was measured as (i) median overall survival (mOS) and (ii) health-related quality of life (HRQoL) in terms of time to symptom worsening (TSW). To assess medical benefits, literature was systematically reviewed in PubMed for (i) and (ii), respectively. Treatment costs were calculated considering annual direct outpatient treatment costs from a statutory healthcare payer perspective. It was intended that both, (i) and (ii), yield an efficiency frontier. Results Annual direct outpatient treatment costs amounted to EUR 176,415.21 (SG), EUR 47,414.14 (eribulin), EUR 13,711.35 (vinorelbine), and EUR 3,718.84 (capecitabine). Systematic literature review of (i) and statistical analysis resulted in OS values of 14.3, 9.56, 9.44, and 7.46 months, respectively. Capecitabine, vinorelbine, and SG are part of the efficiency frontier including OS. The highest additional benefit per additional cost was determined for vinorelbine, followed by SG. Systematic review of (ii) revealed that no TSW data of TNBC patients receiving vinorelbine were available, preventing the presentation of an efficiency frontier including HRQoL. Conclusions Vinorelbine is most cost-effective, followed by SG. Health-economic evaluations support decision-makers to assess treatment options within one indication area. In Germany, the efficiency frontier can provide decision support for the pricing of innovative interventions. Results of our analysis may thus guide reimbursement determination.

show abstract

Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2− Advanced Breast Cancer

Cited by 3 publications

References 24 publications

Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

Head‐to‐head comparison of palbociclib and ribociclib in first‐line treatment of HR‐positive/HER2‐negative metastatic breast cancer with real‐world data from the OPAL registry

Cost-benefit evaluation of advanced therapy lines in metastatic triple-negative breast cancer in Germany

Contact Info

Product

Resources

About