These results mean the growth of the cancer is not fuelled by the hormones estrogen and progesterone, or by the HER2 protein. Triple-negative breast cancer is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. NICE already routinely commissions various drugs for first-line treatment of RCC, including Aveo’s Fotivda (tivozanib), Pfizer’s Sutent (sunitinib) and an Opdivo (nivolumab) Yervoy (ipilimumab) combination - the latter being through the Cancer Drugs Fund. Of note, the small group of patients who received pembrolizumab and paclitaxel in KEYNOTE-355 (13.3 of the entire study population) seemed to have longer PFS durations. Last year, Roche's Tecentriq (atezolizumab), in combination with chemotherapy, became the first immunotherapy regimen to be approved in breast cancer.Įarlier this week, The National Institute for Health and Care Excellence (NICE) released a draft guidance rejecting Keytruda when used in combo with Pfizer’s Inlyta (axitinib) to treat advanced renal cell carcinoma (RCC). The company reminds that in addition to KEYNOTE-355 and KEYNOTE-522, Keytruda is also being evaluated in the same indication in the ongoing KEYNOTE-242 trial. Roger Perlmutter, president of MSD Research Laboratories said that it is “very encouraging” that the drug has “now demonstrated positive results as both a first-line treatment in the metastatic setting with this trial, and as neoadjuvant therapy in the KEYNOTE-522 trial." In the Phase III KEYNOTE-355 trial, the drug was compared in combination with one of three different chemotherapies, to placebo plus one of the three chemotherapy regimens, in patients with locally recurrent, inoperable or metastatic triple-negative breast cancer. The estimated rate of overall survival at 6 months was 80.2 in the pembrolizumab group versus 72.4 in the chemotherapy group (hazard ratio for death, 0.60 95 CI, 0.41 to 0.89 P0.005). We also need to educate oncologists that the dynamic nature of PD-L1 means that it can change with the evolution of the tumour and site of metastatic disease, so careful selection of biopsy site is essential to determining patient eligibility for immunotherapy.MSD has revealed that its cancer blockbuster Keytruda (pembrolizumab) significantly prolonged progression-free survival (PFS) when added to chemo in a triple-negative breast cancer trial. “While we wait for harmonisation, we need to ensure that pathologists and oncologists know which test is needed for which drug. Moreover, there is another companion diagnostic test approved (PD-L1 IHC 22C3 PharmDx) as an aid to identify patients with TNBC who are candidates for pembrolizumab. It reflects the results from the IMpassion130 trial, which supported the EMA approval of ICI plus chemotherapy in PD-L1-positive TNBC.” ( N Engl J Med 2018 379:2108-2121).Īccording to Dieci, research must now focus on better selection of patients and a harmonisation of PD-L1 testing, which is essential to the use of ICIs in this setting. Second, the KEYNOTE-355 trial results are consistent with Impassion130 trial and pembrolizumab is considered as a first-line option of treatment in mTNBC. “Due to the mode of action of immunotherapy, the OS gain can often outperform the PFS gain and this is what we saw in KEYNOTE-355 – with advantages for pembrolizumab over chemotherapy of 4 months and 7 months for PFS and OS, respectively. “These latest findings are really significant in a disease in which OS has remained poor and unchanged for years,” says Dr Maria Vittoria Dieci from the University of Padua, Italy, commenting on the results. Previously, pembrolizumab plus chemotherapy significantly prolonged progression-free survival (PFS) compared with chemotherapy. The KEYNOTE-355 study (NCT02819518) randomized 847 patients with mTNBC 2:1 to receive physician’s choice of chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin) with either pembrolizumab or placebo in the first-line setting. This latest report supports the previous findings from the KEYNOTE-355 study that led to its accelerated approval in this setting by the US FDA last year ( Lancet. Overall survival with pembrolizumab plus chemotherapy in patients with PD-L1-positive (CPS ≥10) metastatic triple-negative breast cancer (Abstract LBA16, ESMO 2021)
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