NCCN Guidelines as published in JNCCN; Bichakjian, et al

The new National Comprehensive Cancer Network (NCCN) guidelines have just been published in the Journal of the National Comprehensive Cancer Network (JNCCN), (Bichakjian, et al). They contain a revised version of the ‘manuscript’, at the end of the guidelines section. To view the guidelines, please click here (Attachment no. 6)

The first-ever phase 3 trial in MCC and is a major academic collaboration across several US cancer centers.
– Poster presentation on Mon, Jun 04

A multicenter, randomized, double-blinded, placebo-controlled, phase 3 trial of adjuvant avelumab (anti-PD-L1 antibody) in Merkel cell carcinoma patients with clinically detected lymph node metastases NCT03271372; Shailender Bhatia et al.
A poster presentation at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting presented data on the ADAM trial. This is the first-ever phase 3 trial in MCC and is a major academic collaboration across several US cancer centres. To view the poster, please click here (Attachment no. 5).

Second-line avelumab treatment of patients with metastatic MCC: Experience from a global expanded access program (EAP);John Walker et al.
A poster presentation at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting presented data on second-line avelumab treatment of patients with metastatic MCC.  The avelumab EAP rapidly enrolled many pts with metastatic MCC and answered an unmet, urgent medical need for patients ineligible for clinical trials or for whom no approved alternative treatments were available. In a real-world setting, avelumab demonstrated safety and efficacy consistent with the Javelin Merkel 200 registrational study. To view the poster, please click here (Attachment no. 4).

Two-year efficacy and safety update from JAVELIN Merkel 200 part A: A registrational study of avelumab in metastatic MCC progressed on chemotherapy;Paul Nghiem et al.

At the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, Dr Suzanne Topalian (John Hopkins Bloomberg~Kimmel Institute for Cancer Immunotherapy), presented data from CheckMate 358, a study on nivolumab as neoadjuvant therapy in patients with resectable MCC. The study showed that nivolumab administered for 4 weeks before surgery in MCC was safe and induced substantial radiologic and pathologic tumour regressions in 45% and 65% of patients, respectively. In some patients, this obviated the need for more extensive surgery. To view the presentation, please click here (Attachment no. 3)

Two-year efficacy and safety update from JAVELIN Merkel 200 part A: A registrational study of avelumab in metastatic MCC progressed on chemotherapy;Paul Nghiem et al.

At the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, Dr Paul Nghiem (University of Washington) presented updated data from the JAVELIN Merkel 200 Part A registrational study. This study showed that at >2 year of follow-up, avelumab shows continued durable responses and meaningful survival patient outcomes in patients with metastatic MCC, exceeding the outcomes associated with cytotoxic chemotherapy. To view the presentation, please click here (Attachment no. 2)

Durable tumor regression and OS in patients with advanced MCC receiving pembrolizumab as first-line therapy;Paul Nghiem et al.
At the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, Dr Paul Nghiem (University of Washington) presented data on patients with advanced Merkel cell carcinoma receiving pembrolizumab as first-line therapy.

This is the longest observation to date of patients with advanced MCC receiving first-line anti-PD-1, which demonstrates durable tumour control, a favourable overall survival rate, and a manageable safety profile. To view the presentation, please click here (Attachment no. 1)

“On Friday 1^st June 2018, Merck/Pfizer announced that the current BAVENCIO (avelumab) metastatic Merkel cell carcinoma access program in Australia will be closed. Any patient request already approved on the access program was grandfathered on Friday, 1^st June, and will continue to receive BAVENCIO stock free of charge until unacceptable toxicity, progression or death.”