Two days three target drugs approved 2020 doomed extraordinary!

The rapid development of new drugs in the field of oncology is also exciting, and in just two days, the new drug at the three target stakes of RET/MET/PARP has been approved by the FDA, bringing infinite vitality to the doomed 2020.
we're going to learn about these three targeted drugs today.
RET Gene May 8, FDA accelerates approval of Lilly's Loxo Oncology LOXO-292 (selpercatinib, LOXO-292) capsules for use: (1) adult metastatic RET fusion positive NSCL Patients with C; (2) adults who require systematic treatment and patients with advanced or metastatic RET mutation-positive thyroid myelin cancer in pediatrics over 12 years of age; (3) adults with systemic treatment of radioactive iodine and patients with advanced or metastatic RET fusion-positive thyroid cancer over 12 years of age.
the incidence of reT gene fusion in NSCLC patients is about 1% to 2%, the incidence of thyroid papilloma cancer (accounting for about 85% of all thyroid cancers) is 10% to 20%, the most common fusion partners include KIF5B, TRIM33, CCDC6 and NCOA4.
the incidence of RET gene mutations in thyroid myelin cancer is about 60%, the most common mutation is M918T.
FDA approval of LOXO-292 is based on the results of a clinical trial involving patients with three types of tumors.
during clinical trials, patients take 160mg LOXO-292 orally twice daily until the disease progresses or becomes untolerated toxic. the main end indicator of
efficacy is the overall remission rate (ORR), which reflects the percentage of patients with reduced tumors and the duration of the remission (DOR).
evaluated the efficacy of LOXO-292 against NSCLC in 105 adult patients who had received treatment for platinum chemotherapy. The ORR was 64%
105 patients.
in patients who responded to treatment, 81% of patients responded for at least six months.
also evaluated the efficacy of 39 patients who had never been treated with RET fusion-positive NSCLC.
these patients had an ORR of 84%.
in patients who responded to treatment, 58 percent of patients responded for at least six months.
evaluated the efficacy of LOXO-292 on MTC in patients with RET mutant MTC (thyroid myeloma) aged 12 and over.
the study recruited 143 patients who had previously received a late or metastatic RET mutation MTC that had been treated with cabozantinib, vandetanib, or both, as well as patients with advanced or metastatic RET mutation MTC who had not been treated with cabotinib or vandetani.
had an ORR of 69% for 55 patients who had previously been treated.
76% of patients who responded to treatment lasted at least six months.
trial also evaluated the efficacy of 88 patients who had not previously received MTC-approved therapy.
these patients had an ORR of 73%.
61% of patients who responded to treatment lasted at least six months.
evaluated the efficacy of LOXO-292 for RET fusion-positive thyroid cancer in adults and pediatric patients over the age of 12.
the study recruited 19 patients with radioactive iodine (RAI) refractive RET fusion-positive thyroid cancer and received another previous systemic treatment, as well as 8 cases of RAI refractive RET fusion-positive thyroid cancer who were not treated any other way. The ORR was 79% for the 19 patients who had been treated before
.
87% of patients who responded to treatment lasted at least six months.
trial also evaluated the efficacy of eight patients who had not received any treatment other than RAI.
these patients have an ORR of 100%.
75 percent of patients who responded to treatment lasted at least six months.
MET Gene May 9, THE FDA approved Novartis Tabrecta (capatinib, INC280) for the treatment of patients with locallate or metastatic MET 14 jump mutations.
Tabrecta is an oral, highly selective small molecule MET inhibitor that inhibits MET phosphorylation caused by hepatic cell growth factor binding or MET amplification, as well as met-mediated downstream signal inglision and the proliferation and survival of MET-dependent cancer cells.
Tabrecta was approved on the basis of a Phase II study called GEOMETRY mono-1.
GEOMETRY mono-1 is a multicenter, open-label phase II clinical study designed to assess the efficacy and safety of Tabrecta single drug treatment sepsis in adult patients with EGFR wild type, ALK re-erunding negative, advanced NSCLC patients with MET amplification or mutation.
the study included 97 NSCLC patients with MET exon 14 jumps, twice a day, at 400 mg. the primary endpoint of
study is ORR, and the secondary endpoint is mitigation duration (DOR).
results showed that Tabrecta had 68 percent ORR for patients with primary treatment, 47 percent of patients with DOR over 12 months, 41 percent effective for patients who had been treated in the past, and 32 percent for patients with pre-treatment and 32 percent for patients with a duration of more than 12 months.
brain metastasis, the effect was also excellent, 13 patients with met 14 mutationwith with brain metastasis, with intracranial ORR reaching 54%, of which 4 cases were completely remissioned to CR.
superior ORR data in the primary patient group showed the clinical correlation between early diagnostic detection and early treatment compared to the treated patient group.
BRCA Gene May 8, AstraZeneca and Mercado jointly announced that the heavy-weight PARP inhibitor Olaparib (The English-language lynparza) developed by the two sides has been approved by the FDA for extended indications, combined with beifdratox as a first-line maintenance therapy for patients with ovarian cancer who have entered full or partial remission after receiving platinum-based chemotherapy.
these patients' tumors are homologous recombinant defects positive (HRD-plus), defined as containing harmful BRCA gene mutations, and/or genomic instability.
approval is based on a randomized double-blind clinical trial called PAOLA-1.
in this study, ovarian cancer patients were treated with olapari-bevacizumab or a placebo-bevacizumab.
Bevacizumab is a VEGF-A inhibitor that is the standard treatment for this type of patient.
study included in fiGO IIIb-IV high-level slurry or endometrial-like ovarian cancer, fallopian tube syntoral cancer or other non-mucus epithelial ovarian cancer patients, after platinum yew alcohol chemotherapy combined with belaval beads monotonica first-line treatment was completely or partially alleviated, and regardless of the preoperative surgery or ABRC mutation status can be entered into the group.
patients were randomly assigned olapari (300 mg, twice a day) or a placebo at a ratio of 2:1 for a total of 24 months, with all patients receiving belaval of muprace every 3 weeks at a dose of 15 mg/kg for a total of 15 months.
test results showed that the median progression survival of the Olapari combination therapy treatment group reached 37.2 months in 387 patients with HRD-positive tumors, and the control group had a median survival of 17.7 months (HR-0.33, 95% CI:0.25-0.45). The total lifetime (OS) data for
patients are not yet mature.
a new drug from research and development to market is not so easy, many new drugs in the early stages of the death, there are some drugs adhere dating to the third phase of clinical, but lost in the final data.
but there are still some clinically superior drugs that have been tested and end up with us.
have to say that this is a time full of miracles, we must be firm confidence, believe that the future of medicine is getting better and better.
Reference Source: 1. FDA Approves First The For Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation Or Fusion; 2. Responseto met ei dat in patients with stage lung IV adenocarcinomas harboring METtts causing exon 14 skipping.doi: 10.1158/2159-8290.CD-14-1467 3. Results of the GEOMETRy i mono-1 phase II study for evaluation of the MET capmatinib (INC280) in patient with MET exon-14 skipping mutated advanced non-small cell cancer. 4. LYNPARZA ® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Advanced Ovarian Cancer. Retrieved May 8, 2020, from.