A very busy week, with a new flu drug approval and lots research announced at all medical meetings.
In time for the new flu season the FDA approved baloxavir marboxil (Xofluza from Roche and Shionogi) on 10/24/18 for the treatment of acute uncomplicated influenza in patients 12 year or older that have been symptomatic for 48 hours or less.
Data from 55 patients in 3 Phase I & II trials involving 17 unique TRK fusion–positive tumor types, suggesting that after 1-year 71% of patients treated with larotrectinib had an ongoing response and 55% remained progression-free. Loxo announced that after two years follow-up, the 55 patients had an overall response rate (ORR) of 80%, partial response rate (PRR) of 62% and a complete response rate (CRR) of 18%. In a group of 67 TRK fusion patients, the ORR was 81%, PFF of 65% and CRR of 17%. When the results of both the 55 patient and 67 patient groups were analyzed together (122 patients), the ORR was 81%, PFF of 63% and CRR of 17%. In a 24 pediatric patient, Phase I trial, larotrectinib was well tolerated and almost all patients with TRK fusion positive cancers had an objective response.
ImmunoGen announced that in the 56 patient, Phase Ib/II, FORWARD II trial, the overall response rate was 30% and progression-free survival was 4.2 months in patients with platinum-resistant epithelial ovarian cancer treated with mirvetuximab soravtansine plus pembrolizumab.
CHMP recommended approval of Sanofi’s Dengue vaccine
AbbVie announced that in the 26-week, 1,629 patient, Phase III, SELECT-COMPARE trial, more patients treated with upadacitinib/methotrexate improved compared to adalimumab/methotrexate or methotrexate monotherapy achieving ACR20 (67%, 57%, 36%), ACR50 (54%, 42%, 21%) and ACR70 (35%, 23%, 10%) in rheumatoid arthritis patients.
Novartis announced that in the 94 patient, open label, Phase II GEOMETRY trial, treatment with capmatinib resulted in an overall response rate of 72% in treatment-naive patients and 39% in previously treated patients with advanced MET exon-14 skipping mutated non-small cell lung cancer.
DBV Technologies submitted a BLA for Viaskin Peanut in October 2018.
Pfizer and Lilly announced that a 16-week, 698 patient, Phase III trial, where treatment with tanezumab 5 mg resulted in a 57% of patients having a 50% improvement in the WOMAC score compared to a 50% with 2.5 mg and a 38% with placebo in patients with osteoarthritis pain of the knee and hip. Rapidly progressive osteoarthritis (RPOA) was observed in 1.3% of tanezumab compared to none with placebo. Most of the RPOA was Type 1, which is characterized by joint space narrowing as compared to the more serious type 2 that is more rapid and leads more often to bone loss and joint destruction. Pfizer and Lilly have 5 ongoing Phase III studies evaluating tanezumab in the treatment of in OA, chronic lower back pain and cancer pain. Results are expected in the first half of 2019.
J&J announced announced preliminary data from the 198 patient, Phase I/IIa TRAVERSE trial suggested that a tetravalent version of the HIV vaccine produced a broadener the immunologic response compared to the trivalent vaccine. Based on preliminary results from the TRAVERSE study demonstrating a broader immunologic response compared the the trivalent vaccine, J&J will advance the tetravalent vaccine into a 2,600 patient Phase IIb trial.
BeyondSpring announced that in a 72 patient, Phase II trial, 50% of patients that received plinabulin and pegfilgrastim experienced neutropenia compared to 81% that received pegfilgrastim monotherapy in patients treated with docetaxel, doxorubicin and cyclophosphamide.
In the 110 patients, Phase II ARADES trial, darolutamide elicited a PSA responses in about a third of men with progressive metastatic castration-resistant prostate cancer. Findings demonstrated that darolutamide monotherapy in this particular group of men provided disease suppression. Bayer and Orion announced preliminary results from the 1,500 patient, Phase II ARAMIS trial, where treatment with darolutamide improved metastasis-free survival compared to placebo in men with non-metastatic castration-resistant prostate cancer.
Biogen announced that in an 18-month, 856 patient, Phase II trial, BAN2401 slowed cognitive decline and reduced beta-amyloid deposits in patients that received the highest dose. The drug had failed a Bayesian statistical analysis at 12 months, but at 18 months, a conventional statistical analysis found a benefit at 6, 12 and 18 months. The findings were criticized because the highest dose group had few patients with a APOE4 mutation that increases the risk for developing Alzheimer’s. Biogen announced that a subgroup analysis suggested that patients with the mutation did better with BAN2401 than those without. However, only 10 patients in the high dose group had the mutation compared to 113 patients with the mutation that received placebo.
Scynexis has two Phase III trials evaluating oral ibrexafungerp for the treatment vulvovaginal candidiasis (VVC) and one trials evaluating the drug for prophylaxis of VVC. Mild to moderate thrombotic events were identified in a Phase I trial of the injectable form of the drug.
Lundbeck announced preliminary information from the 10-week, 697 patient, Phase III, DAYBREAK trial Lu AF35700 was similar to olanzapine and risperidone in patients with treatment-resistant schizophrenia, which missed the primary endpoint of superiority vs conventional therapy.
Ultragenyx announced that in a 44 patient, Phase III trial, triheptanoin was no better than placebo in reducing paroxysmal movements in patients with glucose transporter type 1 deficiency syndrome. After the drug failed the Phase III trial, Ultragenyx has stopped development of triheptanoin as a therapy for glucose transporter type-1 deficiency syndrome (Glut1 DS), but will continue to develop the drug for long-chain fatty acid oxidation disorders.
In the 8-week, 109 patient, Phase II, DUET trial of sparsentan in focal segmental glomerulosclerosis patients, sparsentan reduced proteinuria by 44.8% compared to 18.5% with irbesartan in patients with focal segmental glomerulosclerosis.
In a 42 patient, Phase II trial, treatment with selinexor in combination with low-dose bortezomib and dexamethasone resulted in a 63% overall response rate and progression-free survival of 9 months in patients with relapsed or refractory multiple myeloma.
In a 12 week, Phase I trial, AADvac1 induced an immunological response to pathological tau proteins. No safety issue occurred during the trial and cognition remained stable. In the 72-week, 26 patient, open label FUNDAMANT extension trial, responders retained an immunoglobulin G (IgG) antibody response against the tau peptide at 6-months, but booster doses were required to restore IgG levels. Five patients withdrew from the trial, but there was a trend of slower atrophy in MRI evaluation and lower decline in cognitive assessment in patients with high titers.
In the 12-week,116 patient Phase II, TORTUGA trial, patients treated with filgotinib had a 1.5 point decrease in their Ankylosing Spondylitis Disease Activity Score (ASDAS) compared to a 0.6 decrease with placebo.
A 24-week, 447 patient trial that studied the use of teneligliptan as an add on to metformin therapy showed a 0.3% to 0.63% reduction in HbA1C compared to placebo. In a 12-week, 324 diabetic patient trial, teneligliptan reduced HbA1C by 0.9% to 1% more than placebo. In a 12-week, 194 patient, Phase III trial teneligliptan lowered HbA1C 1% more than placebo.
Mitsubishi Tanabe announced that in a 24-week, 447 patient trial that studied the use of teneligliptan as an add on to metformin therapy, teneligliptan demonstrated a 0.3% to 0.63% reduction in HbA1C compared to placebo. Mitsubishi Tanabe announced that in a 12-week, 324 diabetic patient trial, teneligliptan reduced HbA1C by 0.9% to 1% more than placebo. Mitsubishi Tanabe announced that in a 12-week, 194 patient, Phase III trial teneligliptan lowered HbA1C 1% more than placebo.
In a 12-week, 201 patient, Phase III trial, teneligliptan had a similar reduction in HbA1C 1% compared to sitagliptin (-1.02 vs -1.03) when added to metformin and glimepiride in patients with type 2 diabetes (T2DM) inadequately controlled with metformin and glimepiride.
In a 7-week, 126 patient trial, treatment with cebranopadol resulted in 2.81 mg of daily rescue morphine immediate release given daily over the last 2 weeks of treatment versus morphine in patients with moderate to severe cancer-related pain.
Novo announced that in the 52-week, 731 patient, Phase III Pioneer-8 trial, treated with oral semaglutide 7mg and 14mg lowered HbA1c 0.5 to 1.2% compared to 0% with placebo and weight loss of 1 to 4.3 Kg compared to a 0.6mg gain with placebo in patients with type 2 diabetics.
In a 452 patient, Phase II trial, cefiderocol was non-inferior to imipenem/cilastatin in clinical cure and microbiological eradication in hospitalized adult UTI patients. Cefiderocol has demonstrared activity againset highly resistant Gram-negative bacteria, but has not activity against Gram Positive bacteria.
Eisai announced that in the 4-week, 62 patient, Phase III trial, lemborexant improved 24-hour circadian rhythm pattern reduced nighttime activity compared to placebo in patients with irregular Sleep-Wake Rhythm Disorder (ISWRD) in patients with mild to moderate Alzheimer’s disease.
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