Clinical Catch-up from Last Week: May 20-24

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Biopharma companies never sit still. Almost every week they release results from ongoing clinical trials. Here’s a roundup of some of the top clinical trial news from the previous week.

Japan’s Takeda Pharmaceutical presented more data from its Phase IIIb head-to-head VARSITY clinical trial of Entyvio compared to AbbVie’s Humira in ulcerative colitis. The results show that Entyvio is superior to Humira in treating the disease.

The study evaluated Entyvio (vedolizumab) compared to Humira (adalimumab) in patients with moderately to severely active ulcerative colitis (UC). In March, the VARSITY trial showed that Entyvio was superior to Humira in achieving clinical remission at week 52. The new exploratory data indicated that a larger proportion of patients receiving Entyvio had a clinical response at week 14 compared to those receiving Humira, 67.1% compared to 45.9%, respectively. The differences between the treatment groups were observed as early as week 6, favoring Entyvio.

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Merck & Company announced that its Keytruda failed to hit its primary endpoint in the Phase III Keynote-119 clinical trial. This evaluated Keytruda for second- or third-line treatment of patients with metastatic triple-negative breast cancer. The primary endpoint was superior overall survival compared to chemotherapy.

KEYNOTE-119 is a Phase III trial evaluating Keytruda as a monotherapy compared to physician’s choice of single-agent chemotherapy in metastatic triple-negative breast cancer (TNBC). TNBC is an aggressive type of breast cancer with a high recurrence rate within the first five years after diagnosis. Triple-negative refers to testing negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2. As a result, TNBC does not respond to drugs that target these cancer markers. About 10 to 20% of breast cancers are TNBC.

Boehringer Ingelheim announced that its SENSCIS Phase III clinical trial met its primary endpoint. The trial evaluated the company’s nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

The primary endpoint was reduction in the annual rate of decline in forced vital capacity (FVCa). The drug slowed the loss of pulmonary function in the patients compared to placebo. The cohort receiving nintedanib showed a 44% decrease in the rate of decline of their lung function measured in FVC over 52 weeks.

BioPharmX Corporation announced that the last patient had been dosed in its Phase IIb clinical trial of BPX-04. The compound is a novel topical gel formulation of fully solubilized minocycline to treat papulopustular rosacea. The trial enrolled 206 patients with moderate-to-severe papulopustular rosacea. The trial is comparing BPX-04 versus a control agent over a 12-week treatment period. The trial’s primary endpoint is mean change in the number of facial inflammatory lesions of rosacea from baseline to week 12.

Portola Pharmaceuticals presented data from a subgroup of ANNEXA-4, its Phase IIIb/IV trial of Andexxa, its Factor Xa inhibitor antidote for patients with acute major bleeding. The data revolved around spontaneous intracranial hemorrhage, a brain bleeding event not caused by trauma. Among the 352 patients in the ANNEXA-4 trial, 227 experienced an intracranial hemorrhage. Of them, 128 were treated for it, and 98 were evaluable for hemostatic efficacy. Of this subset, 79%, or 77 out of 98, achieved excellent or good hemostasis, meaning the bleeding stopped, over the 12-hour period after receiving Andexxa.

Eli Lilly’s mirikizumab met the primary endpoint and key secondary endpoints in its Phase II SERENITY trial in patients with moderately- to severely active Crohn’s disease. Patients receiving the drug had significant decreases in clinical and endoscopic measures of disease activity at 12 weeks compared to patients receiving a placebo. The endoscopic response at 12 weeks was 25.8% for 200 mg, 37.5% for 600 mg, 43.8% for 1,000 mg, and 10.9% for those receiving placebo. For the 200 mg, 600 mg and 1,000 mg doses, endoscopic remission was 6.5%, 15.6% and 20.3%, respectively, with 1.6% for the placebo cohort.

OncoSec Medical announced interim data from KEYNOTE-890, an ongoing Phase II trial of its Tavo (intratumoral IL-12) in combination with Merck’s Keytruda in patients with heavily pretreated, metastatic, chemotherapy refractory triple negative breast cancer (mTNBC). Patients who had already failed an average of 3.5 previous chemotherapy regimens were enrolled in KEYNOTE-890 to see if it would provide meaningful clinical activity with Keytruda. In the interim data, there was a rapid tumor reduction of 20% or more at the initial three-month evaluation in the first five of 10 patients. Two patients showed a partial response, one with a 66% reduction, as well as a significant decrease of liver lesions. Four patients showed stable disease, three of which reported a 20% or greater decrease in tumors. Another trial, KEYNOTE-086, showed a 5.3% response rate in mTNBC patients receiving Keytruda alone. The KEYNOTE-890 data, though preliminary, suggests an improvement over Keytruda alone in this difficult to treat patient population.

OncoSec Medical also dosed the first patient in TRIFECTA, a triple combination trial of OncoSec’s TAVO, and IDO1 drug (epacadostat) and Merck’s checkpoint inhibitor Keytruda in patients with unresectable squamous cell carcinoma head and neck (SCCHN) cancer. The triple combination is IL-12, IDO1 and Keytruda, an anti-PD-1 monoclonal antibody. The goal of the trial is to evaluate the combination in SCCHN cancer and potentially evaluate it in other tumor types. Trial is being led by Chase Heaton at the University of California San Francisco (UCSF). Preliminary data from the trial is expected later this year.

CStone Pharmaceuticals and Agios Pharmaceuticals announced that their global Phase III ClarlDHy trial of Tibsovo (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation met its primary endpoint. Cholangiocarcinoma is an aggressive liver cancer. China has one of the highest incidences of cholangiocarcinoma, which is associated with risk factors such as hepatitis B and Clonorchis sinensis infection. Patients treated with Tibosovo reported a statistically significant improvement in progression-free survival (PFS) compared to patients receiving placebo.

Tibsovo is approved in the U.S. for acute myeloid leukemia (AML) with a susceptible IDH1 mutation detected by an FDA-approved test in adults with newly-diagnosed AML who are 75 years of age and older or who have conditions that prevent them from receiving intensive induction chemotherapy, and in adults with relapsed or refractory AML.

BioCryst indicated its Phase III APeX-2 trial for prevention of hereditary angioedema (HAE) hit its primary endpoint. The trial is evaluating BCX7353, a selective plasma kallikrein inhibitor, in HAE, a rare, genetic disorder that affects about one in 10,000 to one in 50,000 people globally. The drug decreased the attack rate in HAE patients by 44% compared to placebo, and also showed a 70% reduction in the HAE attack rate compared to baseline, compared to patients on the placebo cohort who had a 15% reduction.

Tocagen, based in San Diego, reported that after an Independent Data Monitoring Committee (IDMC) conducted a planned interim analysis, its Toca 5 Phase III trial evaluating Toca 511 and Toca FC in recurrent high-grade glioma (HGG) will continue without modification. The studies are evaluating the two-part cancer-selective immunotherapy in patients undergoing resection for recurrent high-grade glioma. The primary endpoint is overall survival (OS).

Toca 511 is a retroviral replication vector (RRV) that selectively infects cancer cells and delivers the gene for the cytosine deaminase (CD) gene. Toca FC is an orally administered prodrug, 5-flurocytosine (5-FC), which concerts into an anti-cancer drug, 5-flurouracil (5-FU) when it encounters CD.

Array BioPharma, based in Boulder, Colo., announced positive results from an interim analysis of its Phase III BEACON CRC trial. This trial is evaluating the combination of Braftovi (encorafenib), a BRAF inhibitor, Mektovi (binimetinib), a MEK inhibitor, and Erbitux (cetuximab), an anti-EGFR antibody (Braftovi Triplet) in patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) after one or two previous lines of therapy. The interim data showed that patients receiving Braftovi Triplet had a statistically significant improvement in overall response rate (ORR) and overall survival (OS) compared to the control, which was cetuximab plus irinotecan-containing therapies.

“Given that there are no therapies currently FDA-approved for this patient population,” stated Scott Kopetz, associate professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, “I believe the results of the BEACON CRC trial will be practice-changing.”

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