Company
(location)

Product

Description

Indication

Status

Date

Amgen Inc. (Thousand Oaks, Calif.)

Vectibix

Panitumumab

Metastatic colorectal cancer

The PEAK study in mCRC patients with RAS wild-type primary tumors of left-sided origin showed that patients receiving Vectibix plus FOLFOX6 as first-line treatment achieved 43.4 months median overall survival (OS), an increase of 11.4 months when compared to FOLFOX6 plus bevacizumab

10/11/16

Ariad Pharmaceuticals Inc. (Cambridge, Mass.)

Brigatinib

Tyrosine kinase inhibitor

ALK+ advanced NSCLC

Showed a confirmed ORR of 62% and median PFS of 12.9 months in patients with ALK+ advanced NSCLC in an ongoing phase I/II trial

10/11/16

Astellas Pharma Europe Ltd. (subsidiary of Astellas Pharma Inc.; Tokyo)

Xtandi

Enzalutamide

Advanced prostate cancer

Data from a study examining the efficacy and safety of enzalutamide versus placebo in 409 Asian patients from China, South Korea, Taiwan and Hong Kong with asymptomatic/mildly symptomatic progressive advanced prostate cancer following androgen deprivation therapy (ADT) found that enzalutamide significantly improved time to PSA progression, compared with placebo (7.46 months vs 2.86 months, respectively)

10/11/16

Astrazeneca plc (London)

Faslodex

Fulvestrant

Advanced breast cancer

Hormonal therapy naive advanced breast cancer patients given Faslodex (fulvestrant) 500 mg during a phase III trial achieved a median progression-free survival (PFS) that was 2.8 months longer than that for patients given another Astrazeneca medicine, Arimidex (anastrozole) 1 mg, in first line treatment; the median PFS was 16.6 months in the fulvestrant arm compared, with 13.8 months in the anastrozole arm

10/11/16

Astrazeneca plc (London)

MEDI4736

Durvalumab

Advanced cancers

Phase Ib/IIa SCORES trial data of durvalumab combined with AZD9150 or AZD5069 showed encouraging anti-tumor activity; with AZD9150, two patients achieved a partial response and five demonstrated stable disease; with AZD5069, one demonstrated CR, two showed PR and five showed stable disease

10/11/16

Astrazeneca plc (London) and Medimmune unit

MEDI4736

Durvalumab

Head and neck squamous cell carcinoma

Efficacy and safety data from the phase I/II trial showed an ORR of 25% in patients with high PD-L1-expressing tumors compared with an ORR of 6% in patients with low or no PD-L1 expression

10/11/16

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Giotrif

Afatinib; second-generation EGFR therapy

EGFR mutation-positive advanced NSCLC

Results from the global phase IIb LUX-Lung 7 trial suggested a reduction in the risk of death of 14% for patients treated with afatinib compared to gefitinib, with a median survival of 27.9 months compared to 24.5 months, respectively

10/11/16

Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Conn.)

Nintedanib

Marketed as Ofev and Vargatef

Metastatic colorectal cancer

LUME-Colon 1 trial, investigating nintedanib plus best supportive care (BSC) vs. BSC alone, met one of the co-primary endpoints of progression-free survival in pre-treated patients with metastatic colorectal cancer (mCRC) who no longer responded to or tolerated other available treatments; but, while nintedanib reduced the risk of disease progression by 42% vs. BSC, the experimental therapy made no difference in overall survival (OS), the second co-primary endpoint

10/11/16

Bristol-Myers Squibb Co. (New York)

Opdivo

Nivolumab

Metastatic renal cell carcinoma

The phase I Checkmate-016 trial, which evaluated the safety and tolerability of Opdivo (nivolumab) at different doses as part of a regimen with Yervoy (ipilimumab), sunitinib or pazopanib in previously treated and treatment-naïve patients with metastatic renal cell carcinoma (mRCC), showed the overall response rate was 40.4% in both arms; the overall survival rate at 12 months was 81% and 85% for Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm and Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm, respectively, and at 24 months was 67% and 70%, respectively

10/11/16

Bristol-Myers Squibb Co. (New York)

Opdivo

Nivolumab

Metastatic urothelial cancer

The CheckMate-275 trial had a confirmed objective response rate (ORR) of 19.6% in platinum-refractory patients; the confirmed ORR in patients expressing PD-L1 ≥1 percent was 23.8% and 16.1% in patients expressing PD-L1 <1 percent; in patients expressing PD-L1 ≥5 percent, the confirmed ORR was 28.4% and 15.8% in patients expressing PD-L1 <5 percent

10/11/16

Bristol-Myers Squibb Co. (New York)

Opdivo

Nivolumab

Recurrent or metastatic squamous cell carcinoma of the head and neck with tumor progression

Results from Checkmate-141, an open-label, randomized phase III study showed Opdivo stabilized patients' symptoms and functioning, including physical, role and social functioning across three separate instruments; both PD-L1 expressors and non-expressors treated with IC therapy experienced statistically significant worsening of patient-reported outcomes from baseline to week 15 versus Opdivo; Opdivo more than doubled the time to deterioration for most functional domains measured and significantly delayed the time to worsening symptoms of fatigue, dyspnea and insomnia, compared to IC therapy

10/11/16

Bristol-Myers Squibb Co. (New York) and Innate Pharma SA (Marseille, France)

Lirilumab

First-in-class antibody directed against the inhibitory killer-cell immunoglobulin-like receptors expressed predominantly on natural killer cells and some T cells

Advanced refractory solid tumors

The safety profile of the combination of lirilumab and nivolumab therapy was similar to that of nivolumab monotherapy, with the exception of an increased frequency of low grade infusion-related reactions in patients treated with the lirilumab combinations

10/11/16

Bristol-Myers Squibb Co. (Princeton, N.J.)

Opdivo

Nivolumab

Advanced lung cancer

CHECKMATE-026, a phase III comparing Opdivo to chemotherapy as first-line therapy in a PD-L1-positive population, failed to meet the primary endpoint of superior PFS compared to chemotherapy and was crushed by the control arm; median PFS was 4.2 months with Opdivo and 5.9 months with platinum-based doublet chemotherapy

10/11/16

Cascadian Therapeutics Inc. (Seattle)

Tucatinib

Selective small molecule HER2 inhibitor

Cancer

Data from phase I trial of eight patients who had been given the maximum tolerated dose in combination with capecitabine and/or trastuzumab showed one complete response, three partial responses and four with stable disease

10/11/16

Celgene Corp. (Summit, N.J.)

Abraxane

Paclitaxel protein-bound particles for injectable suspension; microtubule inhibitor

Non-small-cell lung cancer (NSCLC)

New data from the ABOUND trials demonstrate the continued benefit of Abraxane/carboplatin doublet therapy in NSCLC

10/10/16

Celldex Therapeutics Inc. (Hampton, N.J.)

Glembatu-mumab vedotin

Fully-human monoclonal antibody-drug conjugate that targets glycoprotein NMB

Metastatic melanoma

Positive results from the company's phase II study showed that the primary endpoint of the study (six or more objective responses in the first 52 patients enrolled) was exceeded, with seven of 62 (11%) patients experiencing a confirmed response, and an additional three patients also experienced single time-point responses

10/11/16

Clovis Oncology Inc. (Boulder, Colo.)

Rucaparib

Oral, small molecule inhibitor of PARP1, PARP2 and PARP3

Ovarian cancer

Presented data from subgroups of two phase 2 studies, Study 10 and ARIEL2; the RECIST ORR (objective response rate) in the efficacy population was 57/106, or 54%, including nine (9%) complete responders (CR) and 48 (45%) partial responders (PR); thirty-six patients (34%) had stable disease (SD) as the best response, while nine patients (9%) had progressive disease (PD) as the best response and four (4%) were not evaluable; from Study 10 included in the efficacy population, the RECIST ORR was 25/42, or 60%, including four CRs (10%) and 21 PRs (50%); twelve patients (29%) had SD, and two patients (5%) had PD; for ARIEL2 included in the efficacy population, the RECIST ORR was 32/64, or 50%, including five CRs (8%) and 27 PRs (42%), and 24 patients (38%) had SD and seven (11%) had PD

10/10/16

Corvus Pharmaceuticals Inc. (Burlingame, Calif.)

CPI-444

A selective and potent inhibitor of the adenosine A2A receptor; immunotherapy

Solid tumors

The ongoing phase I/Ib study of CPI-444 as a single agent and in combination with Basel, Switzerland-based Roche AG unit Genentech's Tecentriq (atezolizumab) provided data on optimum dosing, safety and relevant biomarkers

10/11/16

Cytrx Corp. (Los Angeles)

Aldoxorubic-in

Combines chemotherapy agent doxorubicin with a linker molecule that binds directly and specifically to circulating albumin

Advanced sarcomas

Results from its ongoing phase Ib/II trial of aldoxorubicin in combination with ifosfamide/mesna showed that 13 of 36 (36%) patients achieved a partial response of the target lesion by RECIST 1.1 criteria, 22 of 36 (61%) had stable disease, and one patient had progressive disease

10/11/16

Daiichi Sankyo Co. Ltd. (Tokyo)

DS-8201a

A HER2-targeting antibody drug conjugate

Cancer

Preliminary efficacy data from a phase I study suggest that it was well-tolerated with no dose-limiting toxicities

10/11/16

Dynavax Technologies Corp. (Berkeley, Calif.)

SD-101

A second-generation, Toll-like receptor 9 agonist CpG-C class oligodeoxynucleotide

Metastatic melanoma

Findings from an ongoing phase I/II study evaluating SD-101 in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) showed that in patients naïve to anti-PD-1 treatment objective responses were observed in three out of four (75%) including one complete response and two partial responses; one patient with progressive disease while receiving anti-PD-1 therapy was observed to have stable disease

10/11/16

Eisai Ltd. (Hatfield, U.K.)

Halaven

Eribulin

Breast cancer

Results from the CASCADE study showed that with each line of therapy added there was a correlating gradual decline in both objective response rates (ORR) and disease control rates (DCR); in the ONSITE study, hematologic adverse events included febrile neutropenia (n=3, 5%) and neutropenia (n=10, 17%); the most common grade 3-4 non-hematologic adverse events were alopecia (n=3, 5%) and asthenia (n=2, 3%); clinical benefit was seen in 56% of patients (n=33), median PFS was 4.03 months (95% CI 3.07 to 5.93) and at 20 months 77.8% of patients were still alive (n=44)

10/10/16

Endocyte Inc. (West Lafayette, Ind.)

EC1456 and EC1169

An injectable SMDC consisting of folate (vitamin B9) linked to TubBH, and a therapeutic small molecule drug conjugated to TubBH

Prostate cancer

Has shown anti-tumor activity during the dose escalation phase of their respective trials, even in patients not specifically identified as positive for the drug targets; the activity seen to date with EC1169 in prostate cancer patients is particularly encouraging, the firm said, with the first confirmed radiologic partial response recorded

10/11/16

Exelixis Inc. (South San Francisco)

Cabozantinib and Opdivo

Cabozantinib in combination with nivolumab

Genitourinary tumors

Phase I data showed an objective response rate of 43% among the 23 patients who were evaluable for response, with one complete response and nine partial responses; four of six patients (67%) with urothelial cancer achieved a response

10/10/16

Exelixis Inc. (South San Francisco)

Cabozan-tinib

Small molecule inhibitor of the tyrosine kinases c-Met and VEGFR2

Advanced renal cell carcinoma

Results from the CABOSUN randomized phase II trial, it demonstrated a clinically meaningful and statistically significant 31% reduction in the rate of disease progression or death [HR 0.69, 95% CI (0.48-0.99), one-sided P=0.012]; the median progression-free survival (PFS) for cabozantinib was 8.2 months versus 5.6 months for sunitinib, corresponding to a 2.6 months (46%) improvement favoring cabozantinib over sunitinib

10/11/16

Galena Biopharma Inc. (San Ramon, Calif.)

Neuvax

Nelipepimut-S

Breast cancer

Interim safety data from the Neuvax phase IIb combination study with trastuzumab (Herceptin, Roche AG) showed there were no significant differences in treatment factors, but a significant difference in node positivity appreciated between the groups; the majority of toxicities were grade 1 and 2, and there was no difference between treatment arms; there was no difference in EF over time

10/11/16

Genentech Inc. (South San Francisco; member of Roche Holding AG)

Cobimetinib, Zelboraf (vemurafenib) and atezolizumab

Triple combination

Previously untreated BRAF V600 mutation-positive advanced melanoma

Preliminary results from a phase Ib trial showed all-grade adverse events (AEs) occurring in greater than 20% of patients and reported as related to cobimetinib and/or vemurafenib and/or atezolizumab included elevated liver enzymes, fatigue, arthralgia, diarrhea, flu-like symptoms, photosensitivity, increased blood alkaline phosphatase, fever and pyrexia; twelve patients had cobimetinib- and/or vemurafenib and/or atezolizumab-related grade 3/4 AEs during the triple combination period; all resolved after appropriate intervention; the objective response rate was 83%, with 24 patients achieving a response, including three achieving complete responses and 21 achieving partial responses

10/10/16

Genentech Inc. (unit of Roche AG; Basel, Switzerland)

Tecentriq

Atezolizumab; anti-PD-L1

NSCLC

Full data from the pivotal phase III OAK study showed the drug extended survival of the first 850 individuals with previously treated NSCLC who were randomized in the study by a median of 13.8 months to 4.2 months longer than those treated with docetaxel alone (HR = 0.73, 95% CI: 0.62 - 0.87)

10/11/16

Incyte Corp. (Wilmington, Del.)

Epacadostat

Selective IDO1 enzyme inhibitor

Treatment-naïve advanced melanoma

Updated data from the phase I portion of the ECHO-202 trial of epacadostat in combination Keytruda (pembrolizumab, Merck & Co. Inc.) showed that the combination resulted in progression-free survival (PFS) rates of 74% and 57% at six months and 12 months, respectively; the updated data showed an increase in the complete response rate to 26%; the objective response rate and disease control rate remained consistent with the previously published abstract data, at 58% and 74%, respectively

10/10/16

Kite Pharma Inc. (Santa Monica, Calif.)

KTE-C19

Therapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor that is designed to target the antigen CD19

Chemorefractory, aggressive non-Hodgkin lymphoma

Updated results from the phase I portion of its ZUMA-1 trial showed KTE-C19-related adverse events consisted predominantly of cytokine release syndrome (CRS) and neurotoxicity, which were generally reversible, with grade 3 or higher CRS observed in 14% and neurotoxicity in 57%; all were reversible except in one patient with dose-limiting toxicity; it achieved rapid and durable responses in patients with chemorefractory disease (objective response rate 71%; complete remission rate 57%)

10/10/16

Leap Therapeutics Inc. (Cambridge, Mass.)

DKN-01

An anti-DKK1 monoclonal antibody

Advanced biliary cancer

Top-line data from its clinical trial of DKN-01 in combination with gemcitabine and cisplatin showed that the combination was well tolerated and safe at each dose level; at the selected 300 mg DKN-01 dose level, seven of 21 evaluable patients experienced a partial response and 20 patients experienced a partial response or stable disease, representing a disease control rate of 95%

10/11/16

Merck & Co. Inc. (Kenilworth, N.J.)

Keytruda

Pembrolizumab; anti-PD-1 therapy

Ipilimumab-refractory advanced melanoma

Findings from the final overall survival (OS) analysis from the KEYNOTE-002 study showed prolonged overall survival with Keytruda (2 mg/kg and 10 mg/kg), with a median OS of 13.4 months and 14.7 months and a two-year OS rate of 35.9% and 38.2%, respectively, compared to a median OS of 11 months and a two-year OS rate of 29.7% with chemotherapy

10/11/16

Merck & Co. Inc. (Kenilworth, N.J.)

Keytruda

Pembrolizumab; anti-PD-1 therapy

Unresectable or metastatic urothelial cancer

Findings from the phase II KEYNOTE-052 study investigating the use of Keytruda in previously untreated patients who are ineligible for cisplatin-based therapy showed an overall response rate (ORR) of 24% (n=24/100) in the total study population, which included patients with and without PD-L1 expression

10/11/16

Merck & Co. Inc. (Kenilworth, N.J.)

Keytruda

Pembrolizumab; anti-PD-1 therapy

Non-small-cell lung cancer

Showed superior overall survival at 18 months compared to docetaxel in patients with metastatic NSCLC previously treated with platinum-containing chemotherapy whose tumors expressed programmed death ligand 1 - measured as tumor proportion score of 1% or more; in patients with a PD-L1 TPS of 1% or more, OS was 37% at the 2 mg/kg dose and 43% at the 10 mg/kg dose; in all patients, median OS was 10.5 months with 2 mg/kg and 13.6 months with 10 mg/kg compared to 8.6 months with docetaxel

10/11/16

Merck & Co. Inc. (Kenilworth, N.J.)

Keytruda

Pembrolizumab; anti-PD-1 therapy

Squamous and non-squamous NSCLC

In KEYNOTE-024, patients with a PD-L1 TPS of 50% or more, Keytruda offered a 50% reduction in risk of disease progression or death and 40% reduction in the risk of death compared to platinum doublet; median PFS for Keytruda was 10.3 months (95% CI, 6.7-not reached) compared to six months for chemotherapy (95% CI, 4.2-6.2); at six months, 62.1% of patients treated with Keytruda were alive and had no disease progression (95% CI, 53.8-69.4) compared to 50.3% of those receiving chemotherapy (95% CI, 41.9-58.2)

10/11/16

Molecular Partners AG (Zurich, Switzerland)

MP0250

Inhibits VEGF

Cancer

Phase I dose escalation interim results of MP0250 revealed that the drug is generally well tolerated and the side effect profile is consistent with profound inhibition of the VEGF pathway; some signs of clinical activity were seen in the heavily pretreated patients, with two patients showing significant reduction of tumor burden and six patients having prolonged stable disease

10/11/16

Novartis AG (Basel, Switzerland)

LEE011

Ribociclib

Hormone receptor-positive, HER2-negative metastatic breast cancer

Results from the pivotal phase III MONALEESA-2 study show LEE011 plus letrozole significantly extended progression-free survival compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women; the results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone

10/11/16

Novartis AG (Basel, Switzerland)

Tafinlar

Dabrafenib

BRAF V600 mutation-positive advanced melanoma

Tafinlar plus Mekinist demonstrated an overall survival and a progression-free survival benefit; results from the COMBI-v phase III study found the estimated three-year survival rate to be 45% of patients receiving the combination of Tafinlar plus Mekinist compared with 31% of patients who received vemurafenib monotherapy

10/11/16

Novartis AG (Basel, Switzerland)

Zykadia

Ceritinib

NSCLC

Phase II ASCEND-3 data showed that ALK+ NSCLC patients who took Zykadia had a median PFS of 18.4 months; patients who entered the study with brain metastases at baseline had an ORR of 63.3%, similar to patients without brain metastases, who showed an ORR of 64% and DCR of 88%

10/11/16

Oncomed Pharmaceuticals Inc. (Redwood City, Calif.)

Ipafricept

Wnt pathway inhibitors FZD8-Fc; OMP-54F28

Metastatic pancreatic cancer

Patients with previously untreated metastatic pancreatic cancer achieved an overall response rate of 39% in an interim analysis of a phase Ib combination trial of ipafricept, Abraxane (paclitaxel protein-bound particles for injectable suspension) plus gemcitabine

10/11/16

Peregrine Pharmaceuticals Inc. (Tustin, Calif.)

Bavituximab

Chimeric antibody that targets phosphatidylserine

Locally advanced or metastatic non-squamous non-small cell lung cancer

Top-line data from the phase III Sunrise trial suggest pre-treatment levels of beta-2 glycoprotein-1 (beta2GP1) may help to identify patients' responses to therapy; although the trial was discontinued earlier this year, following an interim analysis that failed to demonstrate any difference in overall survival between those on bavituximab plus docetaxel and those on docetaxel only, a planned biomarker analysis showed that patients with baseline levels of beta2GP1 between 200 µg/mL and 240 µg/mL who received bavituximab plus docetaxel achieved 5.5-month improvement (13.2 months vs. 7.7 months) in median overall survival (OS) as compared to patients in the control group with similar beta2GP1 levels; the result was statistically significant (p=0.049; hazard ratio (HR) = 0.67)

10/11/16

Pfizer Inc. (New York)

Inlyta

Axitinib; marketed oral vascular endothelial growth factor

Advanced renal cell carcinoma

Started enrolling treatment-naïve patients onto two separate phase III clinical trials, each of which will evaluate a combination regimen comprising Inlyta and an immune checkpoint inhibitor; it will be paired with Keytruda (pembrolizumab) and avelumab, and compared with Sutent (sunitinib)

10/11/16

Pfizer Inc. (New York)

Sutent

Sunitinib

Renal cell carcinoma

Extended disease-free survival after surgery for more than one year vs. placebo in a phase III trial; median time to disease recurrence for those in the drug treatment group was 6.8 years vs. 5.6 years for those on placebo

10/11/16

Pfizer Inc. (New York)

Xalkori

Crizotinib

NSCLC

Results from the randomized phase III ASCEND-5 study showed that patients previously treated with crizotinib and one or two prior regimens of cytotoxic chemotherapy had a statistically significant and clinically meaningful improvement in median PFS when treated with Zykadia vs. chemotherapy, with a median PFS of 5.4 months for Zykadia vs. 1.6 months for chemotherapy

10/11/16

Pharmamar SA (Madrid, Spain)

Lurbinected-in

PM1183

BRCA1 and BRCA2-associated metastatic breast cancer

Positive results in the 54-patient phase II study showed an average overall response rate of 41%, with 61% of the BRCA2 subgroup and 26% of the BRCA1 group responding; a significant reduction in tumor size was observed in 22 patients

10/11/16

Rexahn Pharmaceuticals Inc. (Rockville, Md.)

RX-3117

A dual DNA and RNA synthesis inhibitor

Metastatic pancreatic cancer

Preliminary efficacy data for RX-3117 in an ongoing phase Ib/IIa trial showed that of patients in stage 1 who had actively progressing disease and a life expectancy of two months, more than 20% had progression-free survival of greater than four months; a further 20% had progression free survival of 2.5 months; RX-3117 was well-tolerated

10/11/16

Seattle Genetics Inc. (Bothell, Wash.)

Enfortumab vedotin (ASG-22ME) and ASG-15ME

Antibody-drug conjugates that target the cell surface proteins Nectin-4 and SLITRK6

Metastatic urothelial cancer

Data for both agents continue to demonstrate overall response rates; safety and recommended phase II doses were also presented for both programs

10/10/16

Tesaro Inc. (Waltham, Mass.)

Niraparib

Once-daily PARP inhibitor

Recurrent ovarian cancer

Phase III NOVA data show it significantly extended the time during which women were able to live with their disease before their tumors began to grow again; the biggest benefit accrued to women with germline BRCA mutations, but statistical significance was also seen in the non-germline BRCA mutant cohort+G231; the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of progression-free survival, with median PFS of 21 months, compared to 5.5 months for control (p<0.0001)

11-Oct

Tracon Pharmaceuticals Inc. (San Diego)

TRC105

Carotuximab

Advanced or metastatic renal cell carcinoma

Median progression-free survival of 11.3 months was observed in a phase Ib trial combining TRC105 with the tyrosine kinase inhibitor Inlyta (axitinib, Pfizer Inc.) in 18 patients

10/11/16

Viralytics Ltd. (Sydney, Australia)

Cavatak

Rhinovirus-derived immunotherapeutic

Melanoma

Positive data from the ongoing phase Ib trial of Cavatak in combination with Yervoy (Ipilimumab, Bristol-Myers Squibb) showed that of 17 melanoma patients, nine had an objective tumor response and five stable diseases

10/11/16

Ziopharm Oncology Inc. (Boston)

Ad-RTS-hIL-12

Gene therapy that controls local expression of interleukin-12

Locally advanced or metastatic breast cancer

Preliminary data from a phase Ib/II study of Ad-RTS-hIL-12 plus veledimex showed that of nine patients in the initial assessment, there was consistent production of IL-12, which in turn produced IFNγ

10/11/16

Notes

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The date indicated refers to the BioWorld Today issue in which the news item can be found.

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