Mosadon keytruda combination therapy reaches the main end point of PFS

Content source: instant medicine On February 12, MSD announced that keytruda (pembrolizumab) combined with chemotherapy (albumin binding paclitaxel, paclitaxel or gemcitabine / carboplatin) reached the primary end point of progression free survival (PFS) in the critical phase 3 keynote-355 clinical trial for the first-line treatment of metastatic triple negative breast cancer (mtnbc) with PD-L1 expression (combined positive score [CPS] ≥ 10) Based on the mid-term analysis conducted by the independent data monitoring committee (DMC), the first-line treatment of keytruda combined with chemotherapy showed statistically and clinically significant improvement in PFS compared with chemotherapy alone Based on DMC recommendations, the trial will continue to evaluate another double primary end point total survival (OS) MSD said it would communicate the data of the trial with regulators and publish the results at the upcoming medical conference "This is a very encouraging result," said Dr Roger M Perlmutter, President of Merck Research Laboratory "Keytruda combined with chemotherapy as a first-line treatment for metastatic TNBC (this keynote-355 trial) and as a new adjuvant treatment (keynote-522 trial) all show positive results." MSD is conducting a number of internal and external collaborative clinical development on keytruda in the treatment of breast cancer, including three ongoing TNBC registration studies (keynote-355, keynote-242 and keynote-522) Last July 29, MSD announced that keytruda combined chemotherapy as a new adjuvant therapy for triple negative breast cancer reached the primary end point of complete pathological remission (PCR) in the phase 3 clinical trial of keynote-522 Keynote-355 is a randomized, two-part, phase 3 trial (nct02819518) to evaluate the efficacy of keytruda in combination with one of three different chemotherapy options (albumin binding paclitaxel, paclitaxel or gemcitabine / carboplatin chosen by the investigator) in the treatment of locally recurrent inoperable or previously metastasized mtnbc compared with placebo plus one of three chemotherapy options Part 1 of the keynote-355 study was open label and evaluated the safety and tolerability of keytruda in combination with albumin binding paclitaxel, paclitaxel, or gemcitabine / carboplatin in 30 patients; Part 2 of the keynote-355 study was a double-blind study in which the dual primary end points OS and PFS, secondary end points package, were evaluated in all subjects and tumor expressing PD-L1 subjects (CPS ≥ 1 and CPS ≥ 10) Including objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety Keynote-355 Part 2 recruited 847 patients who were randomized to receive keytruda plus albumin binding paclitaxel, paclitaxel or gemcitabine / carboplatin, or placebo plus one of three different chemotherapy options The safety characteristics of keytruda in this test are consistent with those observed in the previously reported studies; no new safety signals are found Three negative breast cancer (TNBC) refers to the breast cancer types with negative estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER-2), accounting for 10% - 20% of all breast cancer pathological types, and most of them occur in premenopausal women TNBC is the most dangerous type of breast cancer It is aggressive, easy to metastasize and has a poor prognosis The survival time of patients after diagnosis is usually less than 20 months, and the 5-year survival rate is less than 15% Keytruda is a kind of anti-PD-1 therapy, which has been approved by FDA It can treat more than 10 kinds of cancer indications, such as NSCLC, SCLC, head and neck cancer, liver cancer, kidney cancer and so on In July 2018, keytruda (Coretta, pabolizumab) was approved in China for the treatment of unresectable or metastatic melanoma which failed in the first-line treatment, and became the first PD-1 inhibitor drug for the treatment of advanced melanoma in China; in March 2019, keytruda combined with pemetrexed and cisplatin was approved in China for the first-line treatment of EGFR and alk negative metastatic non squamous non squamous non melanoma Small cell lung cancer; in October 2019, keytruda single drug was used for the first-line treatment of all PD-L1 positive local advanced or metastatic non-small cell lung cancer without EGFR or ALK mutation; in November 2019, keytruda combined with carboplatin and paclitaxel was used for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) reference material: [1] Merck’s KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC) Retrieved 2020-02-12, from https://investors.merck.com/news/press-release-details/2020/Mercks-KEYTRUDA-pembrolizumab-in-Combination-with-Chemotherapy-Met-Primary-Endpoint-of-Progression-Free-Survival-PFS-as-First-Line-Treatment-for-Metastatic-Triple-Negative-Breast-Cancer-mTNBC/default.aspx A kind of