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FDA Extends Date On BMY's SBLA, Genmab Meets Phase 3 Goals, NCNA, LPTX On Watch

pharma 010918 21oct18 lt

Today's Daily Dose brings you news about BioLineRx's promising phase II pancreatic adenocarcinoma trial results; FDA's new decision date for Bristol-Myers Squibb's Opdivo plus low-dose Yervoy sBLA; Dynavax Technologies' SYNERGY-001 study results; Genmab's promising results from phase III CASSIOPEIA study; Leap's promising esophagogastric cancer trial results; NuCana's advanced biliary tract cancer trial results, and OncoMed's encouraging phase Ib trial results in platinum-resistant ovarian cancer.

Read on...

BioLineRx Ltd.'s (BLRX) phase IIa study evaluating BL-8040 in combination with KEYTRUDA in patients with metastatic pancreatic adenocarcinoma has demonstrated encouraging disease control and overall survival, particularly in patients undergoing second-line treatment.

The study, dubbed COMBAT/KEYNOTE-202 study, included 37 patients with metastatic pancreatic adenocarcinoma who had disease progression after one or more previous lines of treatment.

According to the study results, the median overall survival in all patients was 3.3 months, with a 6-month survival rate of 34.4%. In the subpopulation of patients receiving the study drugs as a second-line treatment, the median overall survival was 7.5 months, with a 6-month survival rate of 51.5%.

This compares favorably with historical median overall survival data of 6.1 months for the only currently approved second-line PDAC treatment (a chemotherapy combination of Onivyde, 5-FU and leucovorin).

BLRX closed Friday's trading at $0.98, down 20.97%.

The FDA decision on Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application for Opdivo plus low-dose Yervoy for the treatment of first-line advanced non-small cell lung cancer in patients with tumor mutational burden of more than or equal to 10 mutations per megabase has been extended by 3 months to May 20, 2019.

BMY closed Friday's trading at $54.30, down 3.00%.

Dynavax Technologies Corp.'s (DVAX) interim data from its ongoing phase Ib/II study investigating SD-101 in combination with Merck's (MRK) KEYTRUDA, an anti-PD-1 therapy, in patients with advanced melanoma naïve to anti-PD-1/L1 therapy have been promising.

In the study, dubbed SYNERGY-001, two different doses of SD-101 were tested - less than or equal to 2mg of SD-101 in 1-4 lesions and 8 mg in a single lesion.

The results showed a 70% overall response rate (ORR) in advanced melanoma patients naïve to anti-PD-1/L1 therapy who received the less than or equal to 2 mg dose of SD-101, and a 48% ORR in the group receiving the 8 mg dose of SD-101.

The combination of SD-101 and KEYTRUDA remains well tolerated with adverse events related to SD-101 being transient, mild to moderate flu-like symptoms, added the Company.

DVAX closed Friday's trading at $10.89, down 4.22%.

Genmab A/S (GMXAY.OB) has met the primary endpoint for Part 1 of its phase III study of approved drug DARZALEX (daratumumab) injection in combination with bortezomib, thalidomide and dexamethasone (VTD) versus VTD alone as frontline treatment for multiple myeloma patients who are candidates for autologous stem cell transplant.

In the study, dubbed CASSIOPEIA, the first part of the study met the primary endpoint of number of patients that achieved stringent Complete Response, which was reported in 28.9% of patients treated with DARZALEX in combination with VTD, compared to 20.3% of patients who received VTD alone.

In the second part of the study, patients that achieved a response will undergo a second randomization to either receive maintenance treatment of DARZALEX 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival.

DARZALEX injection for intravenous infusion is approved in the U.S. in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.

The global net sales of DARZALEX as reported by Johnson & Johnson (JNJ) were $1.24 billion in 2017. Net sales were $884 million in the U.S. and net sales in the rest of the world were $358 million. Genmab receives royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

GMXAY.OB closed Friday's trading at $14.20, down 0.84%.

Incyte (INCY), on Friday, announced promising preliminary results from its phase II clinical trial of investigational Capmatinib in 94 adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon-14 skipping mutations.

In the study, dubbed GEOMETRY mono-1, the overall response rate was 72% in treatment-naive patients and 39.1% in previously treated patients.

INCY closed Friday's trading at $66.06, up 2.51%.

Leap Therapeutics Inc.'s (LPTX) ongoing phase I/II study of DKN-01 in combination with Merck's (MRK) Keytruda in patients with advanced esophagogastric cancer has demonstrated promising clinical activity, with a 23.5% overall response rate and 58.8% disease control rate.

The Company is scheduled to host a live conference call and webcast on Monday, October 22 at 8:00 AM US Eastern Time.

LPTX closed Friday's trading at $6.53, down 3.12%.

Shares of Merrimack Pharmaceuticals Inc. (MACK) plunged to a new low, following termination of its phase II trial of MM-121 in patients with heregulin positive in patients with non-small cell lung cancer due to futility.

The trial, dubbed SHERLOC, studied MM-121 in combination with docetaxel, versus docetaxel alone, in patients with heregulin positive NSCLC. An interim analysis showed that the addition of MM-121 to docetaxel did not improve progression free survival over docetaxel alone. Since futility was observed, the study has been terminated.

This is the Company's second phase II trial failure in 4 months.

On June 25, 2018, the Company announced disappointing results from its CARRIE study.

The CARRIE study is a phase II trial evaluating the addition of MM-141 (istiratumab) to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (IGF-1).
The study did not meet its primary or secondary efficacy endpoints in patients who received MM-141 in combination with nab-paclitaxel and gemcitabine, compared to nab-paclitaxel and gemcitabine alone.

MACK closed Friday's trading at $4.01, down 22.29%.

NuCana plc's (NCNA) phase Ib study evaluating Acelarin combined with cisplatin in front-line treatment of patients with advanced biliary tract cancer has achieved approximately a doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin.

In addition, the combination was well-tolerated and several patients achieved significant reductions in their tumor volume as well as further tumor shrinkage over time, added the Company.

In the trial, 14 patients with advanced/metastatic biliary tract cancer received Acelarin and cisplatin on days one and eight of a three-week cycle. In the intent-to-treat group of patients, a Complete Radiological Response was achieved in one patient and a Partial Response in six patients, resulting in an Objective Response Rate of 50%. In the eleven Efficacy Evaluable patients (defined as those patients who received at least one cycle of therapy), an Objective Response Rate of 64% was achieved, according to the Company.

NCNA closed Friday's trading at $20.30, up 18.09%.

OncoMed Pharmaceuticals Inc.'s (OMED) interim results from its ongoing phase Ib trial of Navicixizumab in combination with paclitaxel in patients with platinum-resistant ovarian cancer have been encouraging.

The patients had received a median of four prior therapies, all of whom had received prior paclitaxel and 69% had received prior bevacizumab.

Twenty-two of the 26 patients (85%) treated with the novel regimen of Navicixizumab in combination with paclitaxel experienced clinical benefit. Notably 11 of the 26 patients (42%) achieved a partial response and the median progression-free survival was 5.4 months.

Historical response rates for patients with heavily pretreated platinum-resistant ovarian cancer treated with chemotherapy are typically 15% or less, noted OncoMed.

The trial has been expanded to enroll up to 60 patients with platinum-resistant ovarian cancer (including fallopian tube or primary peritoneal cancers) who have previously received bevacizumab and/or have failed at least two prior therapies, added the Company.

OMED closed Friday's trading at $2.47, down 7.30%.

The FDA, on Friday, approved Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's (SNY) Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

For people with asthma, Dupixent comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose, the Companies noted.

DUPIXENT was approved in the U.S. last March for the treatment of adults with moderate-to-severe atopic dermatitis whose condition is not properly controlled with topical therapies. This biologic therapy is also approved for use in particular patients with atopic dermatitis in other regions of the world, including the European Union, Canada, and Japan.

The drug raked in sales of $256 million in the full year of 2017, and $340 million in the first half of 2018.

REGN closed Friday's trading at $389.83, down 1.36%.

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