On May 17, 2017 Merck KGaA, Darmstadt, Germany, and Pfizer reported that 13 avelumab* abstracts across seven challenging tumor types will be featured at the 53rd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 2-6, 2017 in Chicago, IL (Press release, Pfizer, MAY 17, 2017, View Source [SID1234519225]).

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Key presentations include data for avelumab in first-line metastatic Merkel cell carcinoma (mMCC) and in previously treated metastatic urothelial carcinoma (UC), as well as results from the Phase Ib trial investigating avelumab in combination with the tyrosine kinase inhibitor axitinib, in advanced renal cell carcinoma (RCC).


"Our ASCO (Free ASCO Whitepaper) presence adds to what has already been a momentous year for the alliance, coming shortly after the US FDA granted two accelerated approvals for avelumab," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "We’re particularly excited to share the latest avelumab data in both metastatic Merkel cell carcinoma in the first-line setting and previously treated metastatic urothelial carcinoma with the cancer community."

"Our data at ASCO (Free ASCO Whitepaper) this year underscore the potential of avelumab as a monotherapy treatment, as well as part of combination regimens," said Chris Boshoff, M.D., PhD, Senior Vice President and Head of Immuno-Oncology, Early Development, Translational Oncology, Pfizer Global Product Development. "Now with accelerated approvals in two indications for avelumab in the US, we are entering the next chapter of our clinical development program to provide meaningful new treatment options for patients who need them most."

Highlights of avelumab data at ASCO (Free ASCO Whitepaper) 2017 include the following:

Preliminary data from the ongoing JAVELIN Merkel 200 trial, an open-label, multicenter study conducted in first-line mMCC investigating avelumab in patients who had no prior systemic treatment for mMCC, will be presented for the first time at a medical congress.
Data from a pooled analysis of two metastatic UC cohorts of the JAVELIN Solid Tumor trial, a Phase Ib, open-label, single-arm, multicenter study of avelumab in the treatment of various solid tumors, will be presented.
An oral presentation of results from the JAVELIN Renal 100 trial, a Phase Ib, open-label study evaluating the clinical activity and safety of the combination of avelumab and axitinib for the first-line treatment of advanced RCC.
Beyond mMCC, metastatic UC and advanced RCC, the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer will also showcase avelumab abstracts in non-small cell lung cancer, metastatic castrate-resistant prostate cancer, locally advanced squamous cell carcinoma of the head and neck and relapsed or refractory diffuse large B-cell lymphoma, as well as updated pooled safety data in solid tumors.
The alliance’s JAVELIN clinical development program now involves at least 30 clinical programs, including nine Phase III trials, and more than 5,200 patients across more than 15 tumor types. Results from JAVELIN program trials have supported two FDA accelerated approvals in 2017.

A list of accepted avelumab abstracts is included below. The abstracts are also available on the ASCO (Free ASCO Whitepaper) website.



Abstract ID / Presentation
Title Lead Author Poster No. Date / Time Session
Oral Presentations

Renal Cell Choueiri TK 4504 Monday, June 5 Genitourinary
Carcinoma 8:00-11:00 a.m. (Nonprostate) Cancer
(JAVELIN Renal
100)

First-line
avelumab +
axitinib therapy
in patients with
advanced renal
cell carcinoma:
results from a
phase 1b trial

Poster Sessions

Head and Neck Lee NY TPS6093 Monday, June 5 Head and Neck Cancer
Cancer (TiP) 1:15-4:45 p.m.
(JAVELIN Head and
Neck 100)

JAVELIN Head and
Neck 100: a phase
3 trial of
avelumab in
combination with
chemoradiotherapy
(CRT) vs CRT for
1st-line
treatment of
locally advanced
squamous cell
carcinoma of the
head and neck (LA
SCCHN)

Lymphoma (TiP) Chen R TPS7575 Monday, June 5 Hematologic
(JAVELIN DLBCL) 8:00-11:30 a.m. Malignancies-Lymphoma
and Chronic
Phase 1b/3 study Lymphocytic Leukemia
of avelumab-based
combination
regimens in
patients (pts)
with relapsed or
refractory
diffuse large
B-cell lymphoma
(R/R DLBCL)

Merkel Cell D’Angelo SP 9530 Saturday, June 3 Melanoma/Skin Cancers
Carcinoma 1:15-4:45 p.m.
(JAVELIN Merkel
200)

First-line
avelumab
treatment in
patients with
metastatic Merkel
cell carcinoma:
preliminary data
from an ongoing
study

Merkel Cell Shapiro I 9557 Saturday, June 3 Melanoma/Skin Cancers
Carcinoma 1:15-4:45 p.m.
(JAVELIN Merkel
200)

Exploratory
biomarker
analysis in
patients with
chemotherapy-refr
actory metastatic
Merkel cell
carcinoma treated
with avelumab

Non-Small Cell Gulley JL 9086 Saturday, June 3 Lung Cancer-Non-Small
Lung Cancer 8:00-11:30 a.m. Cell Metastatic
(JAVELIN Solid
Tumor)

Exposure-response
and PD-L1
expression
analysis of
second-line
avelumab in
patients with
advanced NSCLC:
data from the
JAVELIN Solid
Tumor trial

Pan-Tumor Kelly K 3059 Monday, June 5 Developmental
(JAVELIN Solid 8:00-11:30 a.m. Therapeutics-
Tumor) Immunotherapy

Safety profile of
avelumab in
patients with
advanced solid
tumors: a JAVELIN
pooled analysis
of phase 1 and 2
data

Prostate Cancer Fakhrejahani F 5037 Monday, June 5 Genitourinary
(JAVELIN Solid 1:15-4:45 PM (Prostate)
Tumor) Cancer

Avelumab in
metastatic
castration-resist
ant prostate
cancer (mCRPC)

Renal Cell Choueiri TK TPS4594 Sunday, June 4 Genitourinary
Carcinoma 8:00-11:30 a.m. (Nonprostate)
(JAVELIN Renal
101)

Avelumab plus
axitinib vs
sunitinib as
first-line
treatment of
advanced renal
cell carcinoma:
phase 3 study
(JAVELIN Renal
101)

Urothelial Apolo AB 4528 Sunday, June 4 Genitourinary
Carcinoma 8:00-11:30 a.m. (Nonprostate)
(JAVELIN Solid Cancer
Tumor)

Updated efficacy
and safety of
avelumab in
metastatic
urothelial
carcinoma: pooled
analysis from 2
cohorts of the
phase 1b JAVELIN
Solid Tumor study

Publications

Merkel Cell Bharmal M e21070
Carcinoma
(JAVELIN Merkel
200)

Non-progression
during avelumab
treatment is
associated with
clinically
relevant
improvements in
health-related
quality of life
in patients with
Merkel cell
carcinoma

Merkel Cell Kaufman HL e21065
Carcinoma
(JAVELIN Merkel
200)

Patient
experiences with
avelumab vs
chemotherapy for
treating Merkel
cell carcinoma:
results from
protocol-specifie
d qualitative
research

Non-Small Cell Feng Z e20581
Lung Cancer
(JAVELIN Solid
Tumor)

Comparative study
of two PD-L1
expression assays
in patients with
non-small cell
lung cancer
(NSCLC)
*Avelumab is under clinical investigation for treatment of NSCLC, RCC, DLBCL, SSCHN and mCRPC and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for NSCLC, RCC, DLBCL, SSCHN and mCRPC by any health authority worldwide.

About Avelumab

Avelumab is a human antibody specific for a protein called PD-L1, or programmed death
ligand-1. Avelumab is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T-cells, exposing them to anti-tumor responses. Avelumab has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Indications

The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) metastatic Merkel cell carcinoma (mMCC) in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is not approved for any indication in any market outside the US.

Important Safety Information

The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with avelumab include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

For full prescribing information and medication guide for BAVENCIO, please see View Source

Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US

Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US, enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.

All Merck KGaA, Darmstadt, Germany Press Releases are distributed by e-mail at the same time they become available on the Merck KGaA, Darmstadt, Germany Website. Please go to View Source to register online, change your selection or discontinue this service.

On May 17, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported the publication of abstracts for an open-label phase 1b trial in patients with metastatic adenocarcinoma of the pancreas (MAP) (REO 024) and an open-label, randomized, phase 2 study in metastatic castration resistant prostate cancer (mCRPC) (Press release, Oncolytics Biotech, MAY 17, 2017, View Source [SID1234519223]). Data from the studies will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6, in Chicago, IL.

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REO 024, a phase 1b study, was designed to assess the safety (primary endpoint) and dose-limiting toxicity of REOLYSIN in combination with pembrolizumab (KEYTRUDA) and chemotherapy in patients with histologically confirmed MAP who have failed, or did not tolerate, first-line treatment. The study enrolled 11 patients who were given REOLYSIN plus pembrolizumab, along with one of gemcitabine, 5-fluouracil or irinotecan. Grade 1 and 2 treatment emergent adverse events (TEAE) occurred in all patients and Grade 3 and 4 TEAE occurred in eight patients. Three of five efficacy evaluable patients showed a tumor response (secondary endpoint), with one having a partial response (six-month duration) and two having stable disease (lasting 126 and 221 days). Investigators noted that on-treatment biopsies revealed reovirus infection in cancer cells and immune infiltrates and concluded that the combination therapy showed manageable safety profiles and anti-tumour activity in previously treated MAP patients. The abstract, authored by Mahalingam et al, "A study of REOLYSIN in combination with Pembrolizumab and chemotherapy in patients (pts) with relapsed metastatic adenocarcinoma of the pancreas (MAP)," is now available on the ASCO (Free ASCO Whitepaper) annual meeting website.

"We continue to expand our library of clinical data and establish REOLYSIN as safe in combination with KEYTRUDA, a highly promising checkpoint inhibitor," said Dr. Andres Gutierrez, CMO of Oncolytics. "This is a major first step in supporting the adaptive immunity component of our clinical development plan, and it opens the door for additional collaborations with other checkpoint inhibitors as we advance the longer-term, immuno-oncology portion, of the clinical development plan. We look forward to announcing further developments for this program later in the year."

The phase 2 study in prostate cancer was an 85-patient trial designed and executed by the Canadian Cancer Trials Group (CCTG) (IND 209) to assess the therapeutic combination of intravenously-administered REOLYSIN given in combination with docetaxel/prednisone versus docetaxel/prednisone alone in patients with mCRPC. The study did not meet its primary endpoint of 12-week lack of progression, which was comparable in both the test and control arms, or the secondary endpoint of overall survival. The abstract reports significant differences at baseline, where more patients had poor prognostic factors for survival in the test arm versus the control arm. In addition, while the combination of REOLYSIN and docetaxel was tolerated, dose reductions were more common on the test arm with only 51 percent of the patients receiving 90% of the planned dose intensity of docetaxel, versus 76 percent on the control arm.

"In recent years, we and our collaborators have performed numerous phase 1b and phase 2 trials to better understand the anti-tumour mechanisms of REOLYSIN, to identify the best therapies to pair with REOLYSIN, and to identify the cancer indications for which REOLYSIN provides clear benefit," said Dr. Matt Coffey, President and CEO of Oncolytics. "Collectively, these findings reinforce our Clinical Development Plan. While these results themselves indicate that prostate cancer is likely not a viable tumor target, they do not impact our focus on the advancement of REOLYSIN into a phase 3 registration study in patients with metastatic breast cancer. We thank the investigators, staff and patients that participated in these trials that delivered very important data to guide the late stage development of REOLYSIN toward patient populations that can most benefit from its immune-oncology effects."

The abstract, authored by Eigl et al, "A randomized phase II study of pelareorep (REO) plus docetaxel vs. docetaxel alone in patients with metastatic castration resistant prostate cancer (mCRPC): Canadian Cancer Trials Group study IND 209," is now available on the ASCO (Free ASCO Whitepaper) annual meeting website.

On May 18, 2017 MorphoSys reported that it will Present Clinical Data on Proprietary Programs at Upcoming ASCO (Free ASCO Whitepaper) Annual Meeting 2017 (Press release, MorphoSys, MAY 17, 2017, View Source [SID1234519219]).

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Updates on Hemato-Oncological Programs MOR208 and MOR202 will be presented

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the publication of four abstracts accepted for the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2017 in Chicago, Illinois, USA. The abstracts include first data from the phase 2 "L-MIND" combination study with MOR208 and lenalidomide in relapsed/refractory diffuse large B cell lymphoma (DLBCL) as well as data from a phase 1/2a study with MOR202 in patients with relapsed/refractory multiple myeloma. The MOR208 L-MIND abstract has also been selected for the poster discussion session "Targeting CD19 in Aggressive Lymphoma".

"We are delighted to underscore our maturing proprietary development portfolio with new clinical data at the preeminent conference on clinical oncology. The data set will provide additional insight into the progress of our lead cancer compounds MOR208 and MOR202," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

List of abstracts relating to MorphoSys’s proprietary programs

Abstract #7514, poster board #276

L-MIND: MOR208 combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL) – A single-arm phase 2 study

The poster presentation will include preliminary safety and efficacy results from the first patients enrolled in a clinical phase 2 study evaluating MOR208 in combination with lenalidomide in patients with relapsed/refractory (R-R) DLBCL. The poster will be presented during the session, "Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia," to be held on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall). The results will also be highlighted during a poster discussion session on June 5, 2017 (1:15 PM-2:30 PM CDT, room E354b).

Abstract #8024, poster board #350

MOR202 with low-dose dexamethasone (DEX) and in combination with pomalidomide/DEX and lenalidomide/DEX in relapsed or refractory multiple myeloma (RRMM): Interim analysis of a phase 1/2a dose-escalation study

The poster presentation will include matured efficacy and safety data with MOR202 alone as well as in combination with lenalidomide or pomalidomide, plus dexamethasone, for R-R multiple myeloma. The poster will be presented during the "Hematologic Malignancies – Plasma Cell Dyscrasia" session on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall).

Abstract #TPS7571, poster board #330b

B-MIND: MOR208 plus bendamustine (BEN) versus rituximab (RTX) plus BEN in patients with relapsed or refractory (R-R) diffuse large B-cell lymphoma (DLBCL): An open-label, randomized phase 2/3 trial

The poster presentation in the trial-in-progress format will include the design of the phase 2/3 B- MIND study, which will evaluate the treatment of MOR208 plus bendamustine compared to rituximab plus bendamustine in patients with R-R DLBCL who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (SCT). The poster will be presented in the "Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia" session on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall).

Abstract #TPS7567, poster board#328b

COSMOS: MOR208 plus idelalisib or venetoclax in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase inhibitor (BTKi) – A two-cohort phase 2 study

Patients with R/R CLL who discontinue treatment with the BTKi ibrutinib due to progression have a poor prognosis. The poster presentation in the trial-in-progress format will include the design of the COSMOS phase 2 study in patients with R/R CLL receiving a combination treatment of MOR208 with idelalisib or venetoclax. The poster will be presented in the "Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia" session on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall).

The full abstracts can be accessed online here.

On May 18, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from two Phase I studies evaluating the novel cancer immunotherapy CEA-TCB (RO6958688; RG7802), a molecule that binds T-cells and tumour cells simultaneously (Press release, Hoffmann-La Roche, MAY 17, 2017, View Source [SID1234519212]). CEA-TCB was studied in patients with carcinoembryonic antigen (CEA)-positive solid tumours, including microsatellite stable (MSS) metastatic colorectal cancers (mCRC) that overexpress CEA and progressed after at least two prior chemotherapy regimens.1 The studies demonstrated encouraging anti-tumour activity of CEA-TCB as a monotherapy, which was further enhanced in combination with TECENTRIQ (atezolizumab).

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In the monotherapy, out of 31 patients with mCRC treated with CEA-TCB doses of 60mg or above, 14 patients (45%) showed either partial response (n=2, 6%) or stable disease (n=12, 39%). For the combination, of 25 patients treated with doses of 5–160mg of CEA-TCB, 11 patients with MSS mCRC were treated at doses shown to induce tumour lesion inflammation (80 and 160 mg). Nine of these patients (82%) showed either a partial response (n=2, 18%) or stable disease (n=7, 64%) in this difficult-to-treat population.

CEA-TCB showed favourable pharmacokinetics and a manageable safety profile in both monotherapy and combination therapy with TECENTRIQ. Including all adverse events (AEs) in both studies, the majority of AEs were Grade 1–2, with 7.9% being Grade 3 or higher in the monotherapy trial and 8.1% being Grade 3 or higher in the combination trial. Two treatment-related AEs with severity greater than grade 3, (one Grade 4, one Grade 5), occurred in the monotherapy dose escalation at the highest dose level, which exceeded the maximum tolerated dose (MTD) in cycle 1. The results of these Phase I studies will be presented at the 2017 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting which takes place from 2–6 June in Chicago, IL, United States.1

"These early data in heavily pre-treated metastatic colorectal cancer are particularly encouraging because there is a critical need to improve outcomes for people living with this disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "CEA-TCB is currently being further investigated in Phase I clinical trials and has the potential to be combined with a wide variety of other agents. We look forward to continuing the development of this novel cancer immunotherapy across a range of CEA-positive cancers."

CEA-TCB uses a novel 2-to-1 molecular design. It is engineered to bind simultaneously with one arm to CD3 on T-cells and with two arms to CEA on tumour cells, bringing T-cells into close proximity to the cancer cells. This leads to T-cell activation and subsequent tumour cell killing.

A summary of the Phase I results to be presented at ASCO (Free ASCO Whitepaper) are provided below.
Study 1: 80 patients (MSS mCRC: 70) treated; 31 available for efficacy evaluation at data cut-off
Study 2: 45 patients (MSS mCRC: 35) treated; 25 available for efficacy evaluation at data cut-off

About metastatic colorectal cancer
Colorectal cancer (CRC) is the third most common cancer in men (746,000 cases, 10.0% of the total) and the second in women (614,000 cases, 9.2% of the total) worldwide.2 Almost 55% of the cases occur in more developed regions. Incidence rates vary 10-fold in both sexes worldwide.2 The global burden of CRC is expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030.3
About CEA-TCB
CEA-TCB is a novel T-cell bispecific antibody being investigated for the treatment of carcinoembryonic antigen (CEA)-expressing solid tumours. As CEA is overexpressed in a variety of cancers, including colorectal cancer (CRC), CEA-TCB has the potential to work in a broad range of solid tumours. CEA-TCB uses a novel 2-to-1 molecular design. It is engineered to bind simultaneously with one arm to CD3 on T-cells and with two arms to CEA on tumour cells, bringing T-cells into close proximity to the cancer cells. This leads to T-cell activation and subsequent tumour cell killing.