Cancer immunotherapy – what’s new?
There is a lot going on in clinical immunotherapy treatments: expanded indications, new biomarkers and new concepts like CAR-T. Listed below are some developments that stick out from the rest.
Unanimous recommendation for CAR-T
After reviewing the results from the phase 2 ELIANA study, which showed that 82 % of children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia reached complete remission (CR) or CR with incomplete blood count recovery at three months following CTL019 treatment (Tisagenlecleucel, Novartis), the FDA Oncologic Drugs Advisory Committee (ODAC) gave an unanimous recommendation for approval of the treatment.
Kite Pharma’s anti-CD19 chimeric antigen receptor T-cell treatment in patients with diffuse large B-cell lymphoma (DLBCL) showed encouraging results as well. The long-term study included seven evaluable patients with relapsed DLBCL. Of these patients, five demonstrated complete remission and in four these remissions were durable long-term – up to 56 months, and no one has relapsed.
Of course, major side effects are being a big concern with CAR-Ts and Juno Therapeutics had to halt its ROCKET trial that was evaluating JCAR015 in patients with acute lymphoblastic leukemia due to treatment-associated deaths.
Accelerated approval for PD-1 receptor
Nivolumab (Bristol-Myers Squibb) received accelerated approval for the treatment of pediatric and adult patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient metastatic colorectal cancer who have failed prior treatments. The CheckMate-142 trial showed an objective response rate of 28% in patients who had received a prior treatment with fluoropyrimidin, oxaliplatin or irinotecan.
Pediatric indication for Protein 4 Inhibitor
Ipilimumab (BMS) was the first checkpoint inhibitor to be approved for metastatic melanoma in 2011. The indication has now been expanded to include pediatric patients (12 years and older) with unresectable or metastatic melanoma.
peCTLs as predictive biomarkers
In a recently published study a group of researcher attempted to correlate partially exhausted cytotoxic lymphocytes (peCTLs) and regulatory T lymphocyte levels in response to combination immunotherapy in 112 different melanoma tumors.
The results showed that while overall response rates to anti-PD-1 monotherapy and combination therapy were similar in high-peCTL patients, low-peCTL patients given combination therapy demonstrated higher ORRs than those who received monotherapy.