B. Neyns MD, PhD

Highlights in melanoma

SUMMARY

At ASCO 2024, the first results from the phase III NADINA study were presented. Furthermore, the final analysis of the COMBI-AD study demonstrated that one year of adjuvant dabrafenib/trametinib maintains longterm survival benefit in AJCC stage III melanoma. Finally, ASCO featured some interesting presentations on novel strategies to treat melanoma, including the personalised neoantigen vaccine mRNA-4157, the tumour infiltration lymphocyte cell therapy OBX-115, the enhanced oncolytic virus RP2 and neoadjuvant daromun.

(Belg J Med Oncol 2024;18(5):216–20)

Highlights in melanoma

SUMMARY

At ESMO 2023, important advances in the (neo-)adjuvant treatment for patients with cutaneous melanoma were presented, including an exploratory analysis of the SWOG S1801 trial and the results from the phase II Keynote-942 trial. Furthermore, there were some interesting updates on the progress in the treatment of metastatic uveal melanoma and some of the emerging new cellular therapies for metastatic melanoma.

(BELG J MED ONCOL 2023;17(8):281–5)

Rethinking the reimbursement of innovative medicines in oncology: Looking beyond overall survival

SUMMARY

The oncological treatment landscape is evolving at a very rapid pace with a continuous stream of novel treatment options. To fully leverage these therapeutic advances in clinical practice it is important to facilitate a rapid access to innovative anticancer drugs for patients. Specifically for Belgium, the delay from EMA approval to reimbursement for anticancer drugs is very long, with an average of almost 600 days, and a substantial proportion of innovative drugs never make it to the patient. The stringent focus of the Belgian Commission for Reimbursement of Medicines (CRM) on overall survival (OS) data in reimbursement decisions is believed to be an important contributor to this situation. However, the ever-increasing pace at which new anticancer therapies are being developed in combination with an earlier detection of cancer will make it increasingly difficult to present mature OS data at the time of regulatory approval in the years to come. As such, there is an urgent need for a debate with the regulators to consider more readily available endpoints in their reimbursement assessments. In fact, when a strong treatment effect is seen on an intermediate endpoint such as disease-free or progression-free survival, a benefit in OS is quite likely. As such, our reimbursement system needs to be adapted to better align with the scientific progress in oncology. In this, a temporary reimbursement decision based on intermediate endpoints could give Belgian patients earlier access to promising lifesaving medicines. In this, we as oncologists, including specialists in haematology, respiratory oncology, and gastrointestinal cancer, strongly encourage the CRM to use the grading provided by the ESMO magnitude of clinical benefit scale to evaluate the clinical added value of future cancer treatments. This will not only facilitate a faster patient access to innovative therapies, but will also help policy-makers in advancing ‘accountability for reasonableness’ in their resource allocation deliberations.

(BELG J MED ONCOL 2023;17(6):211–5)

Highlights in melanoma

SUMMARY

At ASCO 2023, updated distant metastasis-free survival data from KEYNOTE-716 trial provided additional support for the use of adjuvant pembrolizumab in Stage IIB/IIC melanoma. While a biomarker analysis of the CheckMate 76K study provides some insights into biomarkers that correlate with a greater benefit from adjuvant nivolumab, these factors unfortunately do not allow a selection of the most suitable patients for this therapy in daily practice. In addition to this, promising data were generated with a new immune-oncology strategy combining a personalised therapeutic RNA vaccine and pembrolizumab in patients with stage III melanoma. Finally, a two-year update of the RELATIVITY-047 trial confirmed the benefit of nivolumab plus relatlimab over nivolumab alone in patients with previously untreated, unresectable, or metastatic melanoma.

(Belg J Med Oncol 2023;17(5):89–92)

Highlights in immunotherapy

SUMMARY

Over the last decade, immunotherapy has become an integral part of the oncogenic treatment arsenal. However, the field of immuno-oncology continues to evolve, which was amply illustrated by the large number of studies evaluating innovative immunotherapies presented at ASCO 2022. In this article, we will address some of the more interesting of these studies.

(Belg J Med Oncol 2022;16(5):246–50)

Highlights in immunotherapy

Over the last decade immunotherapy has become an integral part of the oncogenic treatment arsenal. Meanwhile, the field of immune-oncology continues to evolve, which was amply illustrated by the large number of studies evaluating innovative immunotherapies presented at ASCO 2021.

(BELG J MED ONCOL 2021;15(5):218-23)

Highlights in melanoma

At ESMO 2020, most attention in the melanoma field went to studies addressing the benefit of immunotherapy, alone or in combination with other drugs. First of all, updates on the use of immunotherapy in the adjuvant setting were provided for the Keynote-054 and the CheckMate 238 trials. In the advanced melanoma setting, several studies investigating combinations of immunotherapy with targeted agents will be addressed. In addition to this, the ILLUMINATE-204 trial investigates the potential of combining immunotherapy with intratumoral therapy. Similarly, a second study describes the value of local therapy in the treatment of solitary melanoma after progression upon checkpoint inhibitors. Finally, vaccination strategies with an IDO/ PD-L1 peptide vaccine and adjuvant dendritic cell vaccination will be discussed.