FDA approved Keytruda for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. KEYNOTE-522 showed that KEYTRUDA in combination with chemotherapy (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) before surgery and continued as a single agent after surgery significantly prolonged event-free survival (EFS) versus the same neoadjuvant chemotherapy regimens alone in patients with previously untreated stage II or stage III TNBC – there was a 37% reduction in the risk of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause. With this approval, Keytruda is now approved in the US for 30 indications.
FDA approved Keytruda plus chemo for high-risk early-stage TNBC as neoadjuvant treatment
Immutep received FDA and IRB approval in the US for Phase 2b TACTI-003 trial in HNSCC
Immutep announces it has completed all the necessary competent authority steps with FDA and has received IRB approval to commence its Phase 2b TACTI-003 trial in the US. Patient recruitment for the TACTI-003 trial is expected to begin within this quarter. TACTI-003 will evaluate the Immutep’s lead product candidate, eftilagimod alpha in combination with Keytruda as a first line therapy in approximately 154 patients with head and neck squamous cell carcinoma. It is a randomized, controlled clinical study that will take place across Australia, Europe and US in up to 35 clinical sites. Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by FDA in early April 2021. Pending approval by the European and Australian competent authorities and ethics committees, Immutep expects to broaden its recruitment sites into these regions.
CLINICAL
BMS withdraws its US marketing approval for Opdivo as second line treatment of liver cancer
BMS has withdrawn its immunotherapy Opdivo in liver cancer three months after FDA advisory panel recommended not to uphold the drug's 2017 approval in that indication. FDA granted Opdivo monotherapy an accelerated clearance in second-line liver cancer based on a Phase 2 study showing a minority of patients responded to treatment. But BMS wasn't able to confirm, in further testing, that Opdivo helped patients live longer, and other immunotherapies have since proven effective against the disease, leading panelists to vote in April against the drug's continued use. The withdrawal doesn't impact use of Opdivo in combination with BMS’ other immunotherapy, Yervoy, in the same setting in liver cancer, or as a monotherapy in any other indication. But it is the latest result from an ongoing push by U.S. regulators to pull accelerated cancer drug approvals that lack confirmatory data.
Opdivo and Yervoy combination falls short in first-line squamous head and neck cancer
Bristol Myers Squibb’s phase 3 trial measuring the efficacy and safety of Opdivo and Yervoy in platinum-eligible patients with recurrent or metastatic SCCHC. In the study, pitting the drugs against the Extreme treatment regimen in first-line SCCHC, Opdivo and Yervoy failed to show a significant statistical edge. Although Opdivo plus Yervoy showed a clear, positive trend towards OS in patients whose tumors express PD-L1 with a combined positive score (CPS) ≥ 20, the study did not meet its primary endpoints. The safety profile of Opdivo and Yervoy in this trial was consistent with previously reported studies in solid tumors. Opdivo monotherapy previously demonstrated a survival benefit in adults with recurrent or metastatic SCCHN after platinum-based therapy in the CheckMate -141 trial. Based on these results, the FDA and EMA approved Opdivo for this indication in 2016.
