T. Feys MBA, MSc

New oncology reimbursements in Belgium

OVERVIEW OF BELGIAN REIMBURSEMENT NEWS

(BELG J MED ONCOL 2024;18(1):40)

Highlights in HER2-positive breast cancer

The 2023 edition of the San Antonio Breast Cancer Symposium featured the presentation of long-term follow-up data of the KATHERINE trial, confirming the long-term invasive disease free and overall survival benefit of T-DM1 over trastuzumab in patients with HER2+ breast cancer and residual disease after neoadjuvant therapy. ¹ In advanced HER2-positive breast cancer, HER2CLIMB02 showed that adding tucatinib to T-DM1 delays disease progression in previously treated patients, irrespective of the presence of brain metastases.² In addition, a phase II study showed a progression-free survival benefit for the addition of avelumab to vinorelbine and trastuzumab in heavily pre-treated patients with HER2+ metastatic breast cancer.³ Finally, first-line T-DM1 was found to be less effective than trastuzumab-pertuzumab-docetaxel in older patients with HER2+ advanced breast cancer although it did come with a lower toxicity burden.⁴

Highlights in hormone-receptor positive breast cancer

With respect to hormone receptor positive (HR+) breast cancer, SABCS 2023 featured subgroup analyses of the CheckMate 7FL and KEYNOTE-756 trials evaluating perioperative nivolumab or pembrolizumab in patients with early-stage disease.^1,2 Also in early-stage HR+ breast cancer, the final invasive disease free survival (iDFS) analysis of the NATALEE trial was presented evaluating adjuvant ribociclib added to ET.³ In metastatic HR+/HER2- breast cancer, datopotamab deruxtecan was shown to delay disease progression in pre-treated patients.⁴ In the first line treatment for advanced HR+/HER2- breast cancer, SABCS 2023 featured the overall survival (OS) analysis of the MONARCH-3 trial, while INAVO120 demonstrated a progression-free survival (PFS) benefit for the addition of the PI3Kα inhibitor inavolisib to palbociclib and fulvestrant in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer.⁵

Highlights in triple negative breast cancer

While the 2023 annual San Antonio Breast Cancer Symposium (SABCS) did not bring practice-changing data for to the treatment of triple negative breast cancer (TNBC), the general sessions did feature three interesting studies in this breast cancer subtype. First, a 5-year update of KEYNOTE-522 further solidified the clinical benefit of perioperative pembrolizumab in patients with early-stage TNBC.¹ In contrast, the phase III Alexandra/IMpassion030 study failed to show a clinical benefit from the addition of atezolizumab to adjuvant chemotherapy in this setting.² In the advanced setting, the phase II KEYLYNK trial yielded promising results with a combination of pembrolizumab and olaparib following induction therapy with pembrolizumab and chemotherapy in patients with BRCA-mutant, locally advanced, or metastatic TNBC.³

Continued axillary surgery de-escalation in patients with early-stage breast cancer

The role of axillary surgery for patients with early breast cancer has evolved significantly over the past few decades. A number of studies presented at SABCS again showed that de-escalation of axillary surgery has little to no effect on oncologic outcomes and can reduce lymphedema and other unwelcome outcomes for low-risk breast cancer patients.

Downstaging radiotherapy may be feasible without sacrificing oncologic outcomes in patients with early breast cancer

Several trials presented during SABCS 2023 showed that more patient friendly approaches to radiotherapy can lead to similar oncologic outcomes and a lower toxicity compared to more aggressive radiotherapy regimens. Two of these studies will be summarized here.^1,2

Amivantamab plus lazertinib as a first-line treatment for patients with EGFR-mutant advanced NSCLC

Since the publication of the ADAURA trial, osimertinib has been the undisputed standard of care first line treatment for patients with advanced, EGFR-mutant non-small cell lung cancer (NSCLC). Despite a high initial response rate with this agent, most patients treated with osimertinib will eventually relapse. During the 2023 annual meeting of the European Society of Medical Oncology (ESMO), results of the randomized, phase 3 MARIPOSA trial demonstrated that a combination of amivantamab and lazertinib was associated with a better progression-free survival (PFS) and more durable responses than osimertinib in previously untreated advanced, EGFR-mutant NSCLC patients. With these findings, amivantamab plus lazertinib challenges osimertinib as the standard of care in this setting.