On December 13, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported positive results from IMspire150, the phase 3 trial of atezolizumab (TECENTRIQ), cobimetinib (COTELLIC) and vemurafenib (ZELBORAF) in people with previously untreated BRAF V600 mutation-positive advanced melanoma (Press release, Exelixis, DEC 13, 2019, View Source [SID1234552365]). Genentech, Inc. (a member of the Roche Group), Exelixis’ collaborator and the sponsor of the IMspire150 trial, informed the company that the study met its primary endpoint of progression-free survival (PFS). Adding atezolizumab to cobimetinib and vemurafenib helped to reduce the risk of disease worsening or death, compared to placebo plus cobimetinib and vemurafenib.

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A significant and clinically meaningful improvement in PFS was demonstrated in IMspire150. The safety profile observed in the trial was consistent with the known safety profiles of the individual medicines. Results will be presented at an upcoming medical meeting and discussed with health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.

About Advanced Melanoma

Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. When melanoma is diagnosed early, it is generally a curable disease, but most people with advanced melanoma have a poor prognosis. The American Cancer Society estimates there will be more than 96,000 new cases of melanoma and 7,000 melanoma deaths this year in the United States.

In recent years, there have been significant advances in treatment for advanced melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high medical need and a steadily increasing incidence over the past 30 years.

About the IMspire150 study

IMspire150 is a phase 3, multi-center, double-blind, placebo-controlled randomized study in people with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study compared the efficacy and safety of atezolizumab plus cobimetinib and vemurafenib to the combination of placebo plus cobimetinib and vemurafenib. The primary endpoint of the study was investigator-assessed PFS. Key secondary endpoints include PFS by an independent review committee, overall survival, objective response rate, duration of response and other safety and pharmacokinetic measures.

About the Cobimetinib Development Collaboration

Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a worldwide collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop cobimetinib.

Under the terms of the collaboration, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and shares U.S. commercialization costs. Outside of the United States, Exelixis is eligible to receive royalties on any sales.

Cobimetinib is also the subject of a clinical development program aimed at evaluating its potential in combination with investigational and approved therapies in multiple disease settings.

TECENTRIQ (atezolizumab), COTELLIC (cobimetinib) and ZELBORAF (vemurafenib) are registered trademarks of Genentech, a member of the Roche Group.

COTELLIC Indication

Important: If a patient’s healthcare provider prescribes ZELBORAF (vemurafenib), the patient should also read the Medication Guide that comes with ZELBORAF.

COTELLIC is a prescription medicine that is used with the medicine ZELBORAF to treat a type of skin cancer called melanoma:

that has spread to other parts of the body or cannot be removed by surgery, and
that has a certain type of abnormal "BRAF" gene.
A patient’s healthcare provider will perform a test to make sure that COTELLIC is right for the patient. It is not known if COTELLIC is safe and effective in children under 18 years of age.

Important Safety Information

Before taking COTELLIC, patients should tell their healthcare provider about all of their medical conditions, including if they:

have skin problems or history of skin problems, other than melanoma
have bleeding problems, any medical conditions and/or on any medications that increase the risk of bleeding
have heart problems
have eye problems
have liver problems
have muscle problems
are pregnant or plan to become pregnant. COTELLIC can harm an unborn baby.
Females who are able to become pregnant should use effective birth control during treatment with COTELLIC, and for two weeks after the final dose of COTELLIC.
Patients should talk to their healthcare provider about birth control methods that may be right for them.
Patients should tell their healthcare provider right away if they become pregnant or think they are pregnant during treatment with COTELLIC.
are breastfeeding or plan to breastfeed. It is not known if COTELLIC passes into breast milk. Patients should not breastfeed during treatment with COTELLIC and for two weeks after the final dose of COTELLIC. Patients should talk to their healthcare provider about the best way to feed their baby during this time.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain medicines may affect the blood levels of COTELLIC.

Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.

How should patients take COTELLIC?

Patients should take COTELLIC exactly as their healthcare provider tells them. Patients should not change their dose or stop taking COTELLIC unless their healthcare provider tells them to.
Patients should take COTELLIC one time a day for 21 days, followed by seven days off treatment, to complete a 28-day treatment cycle.
Patients can take COTELLIC with or without food.
If a patient vomits after taking their dose of COTELLIC, they should not take an additional dose. Patients should take their next dose as scheduled.
If a patient misses a dose of COTELLIC, they should take their next dose as scheduled.
What should patients avoid during treatment with COTELLIC?

Patients should avoid sunlight during treatment with COTELLIC. COTELLIC can make a patient’s skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn:

When a patient goes outside, they should wear clothes that protect their skin, including their head, face, hands, arms and legs.
They should use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
What are the possible side effects of COTELLIC? COTELLIC may cause serious side effects, including:

Risk of new skin cancers. COTELLIC may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma or basal cell carcinoma).
Patients should check their skin regularly and tell their healthcare provider right away if they have any skin changes including:

new wart
skin sore or reddish bump that bleeds or does not heal
change in size or color of a mole
A patient’s healthcare provider should check the patient’s skin before they start taking COTELLIC, and every two months during treatment with COTELLIC. A patient’s healthcare provider may continue to check the patient’s skin for six months after the patient stops taking COTELLIC.

A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients should tell their healthcare provider about any new symptoms that develop during treatment with COTELLIC.

Bleeding problems. COTELLIC can cause serious bleeding problems. Patients should call their healthcare provider and get medical attention right away if they get any signs of bleeding, including:
red or black stools (looks like tar)
blood in their urine
headaches
cough up or vomit blood
stomach (abdominal) pain
unusual vaginal bleeding
dizziness or weakness
Heart problems. A patient’s healthcare provider should do tests before and during treatment to check the patient’s heart function. Patients should tell their healthcare provider if they get any of these signs and symptoms of heart problems:
persistent coughing or wheezing
shortness of breath
swelling of their ankles and feet
tiredness
increased heart rate
Severe rash. Patients should tell their healthcare provider right away if they get any of these symptoms:
a rash that covers a large area of their body
blisters
peeling skin
Eye problems. Patients should tell their healthcare provider right away if they get any of these symptoms:
blurred vision
partly missing vision or loss of vision
see halos
any other vision change
A patient’s healthcare provider should check the patient’s eyes if the patient notices any of the symptoms above.

Liver problems. A patient’s healthcare provider should do blood tests to check the patient’s liver function before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
yellowing of their skin or the white of their eyes
dark or brown (tea color) urine
nausea or vomiting
feeling tired or weak
loss of appetite
Muscle problems (rhabdomyolysis). COTELLIC can cause muscle problems that can be severe. Treatment with COTELLIC may increase the level of an enzyme in the blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. A patient’s healthcare provider should do a blood test to check the patient’s levels of CPK before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
muscle aches or pain
muscle spasms and weakness
dark, reddish urine
Skin sensitivity to sunlight (photosensitivity). Skin sensitivity to sunlight during treatment with COTELLIC is common and can sometimes be severe. Patients should tell their healthcare provider if they get any of these symptoms:
red, painful, itchy skin that is hot to touch
sun rash
skin irritation
bumps or tiny papules
thickened, dry, wrinkled skin
See "What should patients avoid during treatment with COTELLIC?" for information on protecting the skin during treatment with COTELLIC.

The most common side effects of COTELLIC include:

diarrhea
nausea
fever
vomiting
A patient’s healthcare provider will take blood tests during treatment with COTELLIC. The most common changes to blood tests include:

increased blood levels of liver enzymes (GGT, ALT or AST)
increased blood level of enzyme from muscle (creatine phosphokinase)
decreased blood level of phosphate, sodium or potassium
increased blood level of liver or bone enzyme (alkaline phosphatase)
decreased blood level of a type of white blood cell (lymphocyte)
These are not all the possible side effects of COTELLIC. Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

On December 13, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, and Mirati Therapeutics (NASDAQ:MRTX), a clinical-stage targeted oncology company, reported preliminary data from an ongoing Phase 1b trial of investigational anti-PD-1 antibody tislelizumab in combination with investigational tyrosine kinase inhibitor sitravatinib in patients with platinum-resistant ovarian cancer, which demonstrated antitumor activity and was generally well tolerated (Press release, BeiGene, DEC 13, 2019, View Source [SID1234552364]). Results from the Phase 1b clinical trial were presented at the 2019 European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress on December 13, 2019 in Geneva, Switzerland.

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"Tislelizumab and sitravatinib have both demonstrated antitumor activity as single agents, so we’re encouraged by the early evidence showing the potential for these two agents to work together to treat advanced solid tumors, including platinum-resistant ovarian cancer," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "We continue to make progress in the collaboration with Mirati Therapeutics and we look forward to continued enrollment in the trial and further clinical data on the combination of tislelizumab and sitravatinib, a compound that has a unique tyrosine kinase inhibition profile."

"We were eager to enter into this collaboration with BeiGene because we believe sitravatinib, a spectrum-selective receptor tyrosine kinase inhibitor, may help increase the activity of anti-PD-1 antibodies such as tislelizumab in patients whose solid tumors exhibit resistance," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer, Mirati Therapeutics, Inc. "The initial results from this Phase 1b trial suggest further development of this combination for the treatment of advanced solid tumors, including platinum-resistant ovarian cancer, is warranted."

Summary of Preliminary Results from the Phase 1b Trial in Platinum-Resistant Ovarian Cancer

Abstract 94O

This open-label, multi-center Phase 1b trial (NCT03666143) of tislelizumab in combination with sitravatinib consists of nine disease-specific cohorts in patients with advanced solid tumors. The results presented at ESMO (Free ESMO Whitepaper) I-O were from cohort E in 20 patients with recurrent platinum-resistant ovarian cancer who did not have prior exposure to anti-PD-1/PD-L1 agents. Patients were treated with tislelizumab at 200 mg IV every three weeks and sitravatinib at 120mg orally once daily. At the data cutoff of July 17, 2019, 17 patients were evaluable and preliminary results included:

Seven patients achieved a partial response (PR), including four confirmed PRs; the overall response rate (ORR) was 23.5% (4/17, 95% CI: 6.8%, 49.9%); eight patients achieved stable disease (SD);

The median duration of response (DoR) was not reached (95% CI: 12.29 weeks, not reached);

The median progression-free response (PFS) was 18 weeks (95% CI: 12.29 weeks, not reached), and the PFS rate at 3 months and 6 months was 88.2% (95% CI: 60.6%, 96.9%) and 35.3% (95% CI: 9.0%, 63.8%), respectively;

All 20 patients in this cohort experienced treatment-emergent adverse events (TEAEs) of any grade;

Fifteen patients (75%) experienced at least one grade ≥ 3 TEAE, with the most common being hypertension (25%) and fatigue (10%);

Immune-related TEAEs were hypothyroidism (20%), diarrhea (15%), and rash (15%);

Six patients (30%) discontinued the study treatment due to TEAEs; and

Two patients experienced TEAEs leading to death, abdominal pain and respiratory failure, both of which were considered unrelated to treatment by the study investigator.
BeiGene and Mirati entered into an exclusive license agreement for the development, manufacturing and commercialization of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and New Zealand in January 2018. Clinical trials for tislelizumab and sitravatinib are ongoing in patients with non-small cell lung cancer, renal cell carcinoma, melanoma, hepatocellular cancer and gastric cancer.

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Select ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric cancer (GC); a Phase 3 clinical trial in first-line patients with ESCC; and a Phase 2 clinical trial in second- or third-line patients with HCC. The aforementioned trials are enrolling patients in multiple countries, including the United States, Europe, and China.

In addition to a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL) and a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic urothelial cancer, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with first-line nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); a Phase 3 clinical trial in patients with localized ESCC; and a Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies have been enrolling patients primarily in China.

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted and granted priority review by the China National Medical Products Administration (NMPA, formerly known as CFDA). BeiGene has full development and commercial rights to tislelizumab worldwide.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combinations of anti-PD-1 checkpoint inhibitors, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

Sitravatinib is also being evaluated as a single-agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma.

On December 13, 2019 OncoSec Medical Incorporated ("OncoSec") (Nasdaq:ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported interim results from KEYNOTE-890, an ongoing Phase 2 study of TAVO (intratumoral IL-12) in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 checkpoint inhibitor, in patients with metastatic, chemotherapy-refractory triple negative breast cancer (mTNBC) (Press release, OncoSec Medical, DEC 13, 2019, View Source [SID1234552363]).

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Patients who previously had progressed after an average of three prior lines of chemotherapy were enrolled in the KEYNOTE-890 study to evaluate if the addition of TAVO could provide meaningful clinical activity when combined with KEYTRUDA. The interim analysis, presented on December 12, 2019, at the San Antonio Breast Cancer Symposium, included more than half of the patients (14 out of 25) enrolled in the KEYNOTE-890 study evaluating tumor responses, related immunological responses and safety.

Four of the 14 patients showed a rapid tumor reduction and had a confirmed partial response by RECIST v1.1 (ORR 28.5%), including a deep partial response in a patient with multiple liver, bone, skin and nodal metastases and a short disease-free interval following neoadjuvant chemotherapy. All responses are ongoing (range: 6 to 9 months) and a median duration of response (DOR) has not yet been reached. Three of the four patients with a partial response experienced deepening tumor shrinkage over six months.

These interim findings compare favorably to the response rate (range of 6-10%) observed with KEYTRUDA as a monotherapy in mTNBC patients 1,2.

Stable disease was observed in three patients (21.4%), with two stable disease patients reporting 20% or greater tumor shrinkage. Of the seven patients who progressed following treatment, two received only one cycle of combination treatment prior to rapid clinical deterioration. Regression of both TAVO treated and untreated lesions were observed. Regression of distal visceral lesions were also observed. Additionally, 3 of the 4 responding patients’ lesions were PD-L1 negative by IHC analysis before treatment (1 patient was undetermined).

"Metastatic TNBC is a heterogeneous disease with a poor prognosis where very few pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint inhibitor therapy," said Melinda L. Telli, MD, Stanford University School of Medicine. "These preliminary data suggest that TAVO may enhance sensitivity to pembrolizumab in mTNBC patients with a 28.5% ORR reported. I’m encouraged by the tumor responses observed in PD-L1 negative patients and the overall safety profile."

Importantly, TAVO and pembrolizumab were well tolerated, with only 3 of 16 patients experiencing grade 3 treatment-related adverse events with combination treatment.

Patients demonstrated encouraging immunological responses in tumor and blood consistent with an IL-12-associated mechanism of action, including significantly increased on-treatment proliferating T cell subsets in the periphery and increased gene expression signatures associated with productive immunological responses in the tumor. Biomarker analysis of patient tumor and blood samples are ongoing.

"These data show a strong signal for clinical benefit with TAVO enhancing sensitivity to pembrolizumab in treating metastatic TNBC patients who were previously unresponsive to multiple prior rounds of therapy," said Kellie Malloy, Chief Clinical Development Officer at OncoSec. "They also confirm the consistent safety profile of TAVO as a well-tolerated cancer immunotherapy. We look forward to continuing development and plan to expand this clinical program and the KEYNOTE-890 trial."

To date, the KEYNOTE-890 study has enrolled 24 of the planned 25 patients. OncoSec expects to report the full data results in 2020.

About Triple Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 10-20% of patients with breast cancer are diagnosed with TNBC.

About KEYNOTE-890

KEYNOTE-890 is designed as a multicenter Phase 2 open-label trial focusing on patients with a histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. 25 patients are expected to be enrolled. Each patient will undergo 3-week treatment cycles with pembrolizumab administered as a 30-minute IV infusion day 1 of every cycle (flat dose of 200 mg) and treated with TAVO on days 1, 5 and 8 every six weeks.

On December 13, 2019 Omeros Corporation (Nasdaq: OMER) ("Omeros"), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported the full exercise and closing of the sale of 572,518 shares of common stock to the underwriter of its previously announced public offering pursuant to the underwriter’s option under the underwriting agreement to purchase additional shares of common stock (Press release, Omeros, DEC 13, 2019, View Source [SID1234552362]). When combined with shares sold in the closing that occurred on December 9, 2019, Omeros sold an aggregate of 4,389,311 shares of common stock in the offering at $13.10 per share and the total gross proceeds to Omeros, before deduction of underwriting discounts and other estimated offering expenses, were approximately $57.5 million.

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Cantor Fitzgerald & Co. acted as the sole book-running manager for the offering.

Omeros intends to use the net proceeds from the offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization. Omeros may also use the net proceeds for working capital, the repayment of debt obligations, acquisitions or investments in businesses, products or technologies that are complementary to its own, and other required capital expenditures.

The securities described above were offered by Omeros pursuant to a shelf registration statement on Form S-3 (File No. 333- 235349) that was filed with the Securities and Exchange Commission (the "SEC") on December 4, 2019, which became automatically effective upon filing. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on December 6, 2019 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected].

On December 13, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors has approved a first-quarter 2020 dividend of $0.16 per share (Press release, West Pharmaceutical Services, DEC 13, 2019, View Source [SID1234552361]). The dividend will be paid on February 5, 2020, to shareholders of record as of January 22, 2020.

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On December 10, 2019, the Company’s Board of Directors authorized a share repurchase program for calendar-year 2020 authorizing the repurchase of up to 848,000 shares of the Company’s common stock from time to time on the open market or in privately-negotiated transactions, as permitted under Exchange Act Rule 10b-18. The number of shares to be repurchased and the timing of such transactions will depend on a variety of factors, including market conditions. The share repurchase program is expected to be completed by December 31, 2020. The Company’s previously-authorized share repurchase program will expire on December 31, 2019.

The Company also announced that management will be presenting an overview of the business at the J.P. Morgan Healthcare Conference in San Francisco, California, at 4:30 p.m. PST on Wednesday, January 15, 2020.

A live audio webcast of the presentations and a copy of the presentation materials will be accessible from the Company’s website at www.westpharma.com/en/investors.