The second expansion cohort in ProTarget will provide evidence on whether patients with BRAF-mutated neuroendocrine carcinoma will benefit from BRAF/MEK-inhibitor treatment

The cohort including patients (pts.) with BRAF V600-mutated neuroendocrine carcinoma (NEC) for treatment with Cotellic (cobimetinib) and Zelboraf (vemurafenib) has completed the first stage of accrual. The cohort has been evaluated and since treatment benefit is seen for ≥1 pt. in the cohort, the investigator group has decided to expand the cohort to stage 2 enrollment, which will include 24 pts. in total.

“This is an important step for the trial and the patients. There is indeed a medical need. I am confident that we will be able to complete the next stage with our international collaborators to provide additional evidence.”

Professor Ulrik Lassen, Study Principal Investigator, ProTarget.

The combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib) is approved by EMA for treatment of BRAF V600-mutated metastatic melanoma. However, in ProTarget this combination therapy is tested outside the approved label in pts. with BRAF-V600 mutated advanced cancer. Patients are included in cohorts defined by their genomic drug-match and tumor type, e.g., BRAF-mutated NEC, and must have exhausted all standard treatment options to be eligible for treatment. The expansion of this cohort may provide us with data indicating treatment benefit in this patient group.

When the cohort completes second stage of accrual, patient characteristics, response and toxicity data will be summarized and evaluated. If at least 5 pts. demonstrate benefit of treatment, further investigations may be initiated. One option is to enter stage 3 in collaboration with other DRUP-like trials in Europe by pooling data and continue patient inclusion across the trials within the PrimeRose consortium, a Horizon 2022 project funded by the European Union. Zelboraf (vemurafenib) and Cotellic (cobimetinib) are supplied by Roche.