On May 10,2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported its financial and operational results for the first quarter ended March 31, 2018 (Press release, Sierra Oncology, MAY 10, 2018, View Source [SID1234526417]).

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"In late February 2018, we provided a comprehensive update on the development program for our Checkpoint kinase 1 (Chk1) inhibitor, SRA737. We also announced planned amendments to our SRA737 Monotherapy Phase 1/2 trial that are now being implemented, which include expanding the overall size of the trial and adding a sixth cohort targeting CCNE1-driven high grade serous ovarian cancer (HGSOC). This cohort is of high interest to us given mounting evidence for the role that CCNE1 amplification has in driving replication stress in cancer and the corresponding reliance on Chk1 in order to manage this replication stress. Analogous to poly ADP-ribose polymerase (PARP) inhibitors, which first exhibited robust activity in patients harboring BRCA mutations, emerging evidence suggests that Chk1 inhibitors such as SRA737 may prove effective in defined genetic backgrounds of high replication stress, such as CCNE1 amplification," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We are also pleased to report that we have advanced our Phase 1/2 Low-Dose Gemcitabine Combination trial into the Cohort Expansion Phase 2 portion, which is targeting enrollment of 80 genetically-selected patients across four indications, with a comparable biological orientation based on both exogenous (low-dose gemcitabine) and intrinsic genetic drivers of replication stress. An update from this trial and preliminary data from the Monotherapy trial are anticipated in the fourth quarter of 2018."

During the first quarter, Sierra reported signing a supply agreement with Janssen Research & Development, LLC pursuant to which they will supply TESARO’s ZEJULA (niraparib), an orally administered PARP inhibitor, facilitating the initiation of a combination trial of niraparib with SRA737 in patients with prostate cancer in the fourth quarter of 2018. The trial is to be led by Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.

Subsequent to the end of the quarter, Sierra presented preclinical results for SRA737, including late-breaking data, in two posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting, demonstrating that SRA737 has anti-tumor activity across a broad range of settings, including as monotherapy in aggressive CCNE1-driven HGSOC patient-derived xenografts and in combination with a PARP inhibitor in tumor cells that have acquired resistance to PARP inhibitors and/or platinum therapy.

Sierra is also currently designing a clinical study evaluating SRA737 in combination with immuno-oncology agents, which potentially could be submitted to regulatory authorities in the fourth quarter of 2018.

In addition to SRA737, Sierra is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of cell division cycle 7 kinase (Cdc7). SRA141 is currently undergoing preclinical research in preparation for an Investigational New Drug Application (IND) submission to the U.S. Food and Drug Administration (FDA) expected in the second half of 2018.

First Quarter 2018 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $8.3 million for the first quarter of 2018, compared to $8.0 million for the first quarter of 2017. The increase was primarily due to an increase of $1.7 million in clinical trial costs partially offset by decreases of $0.9 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.5 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $1.0 million for both the first quarter of 2018 and of 2017.

General and administrative expenses were $3.4 million for the first quarter of 2018, compared to $3.1 million for the first quarter of 2017. This increase was primarily due to an increase in personnel-related costs and professional fees. General and administrative expenses included non-cash stock-based compensation of $0.5 million for both the first quarter of 2018 and of 2017.

Net loss was $11.5 million for the first quarter of 2018, compared with a net loss of $11.1 million for the first quarter of 2017.

Cash and cash equivalents totaled $133.8 million as of March 31, 2018, compared to $100.3 million as of December 31, 2017. This increase was due to an underwritten public offering of 21,850,000 shares of common stock in March 2018, pursuant to which the company raised net proceeds of $46.0 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2020. At March 31, 2018, there were 74,309,681 shares of common stock issued and outstanding and stock options to purchase 10,202,831 shares of common stock issued and outstanding.

On May 10,2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the first quarter ended March 31, 2018 (Press release, Checkpoint Therapeutics, MAY 10, 2018, https://www.cnbc.com/2018/05/10/globe-newswire-checkpoint-therapeutics-reports-first-quarter-2018-financial-results-and-recent-corporate-highlights.html [SID1234526473]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "In the first quarter of 2018, Checkpoint continued to execute on milestones to advance the development of our lead immuno-oncology and targeted therapy clinical programs, while also strengthening our financial position. Notably, we completed an underwritten public offering in March, raising net proceeds of $20.8 million to continue to fund our development programs, and initiated the first dose expansion cohorts in the Phase 1 trials of CK-301, our fully human anti-PD-L1 antibody, and CK-101, our third-generation EGFR inhibitor. We look forward to reporting initial data from these expansion cohorts in the second half of 2018, and are targeting the initiation of our first registration trial for CK-301 in first-line non-small cell lung cancer in the first quarter of 2019."

Financial Results:

Cash Position: As of March 31, 2018, Checkpoint’s cash and cash equivalents totaled $34.9 million, compared to $19.2 million at December 31, 2017, an increase of $15.7 million.
R&D Expenses: Research and development expenses for the first quarter of 2018 were $6.9 million, compared to $3.7 million for the first quarter of 2017, an increase of $3.2 million.
G&A Expenses: General and administrative expenses for the first quarter of 2018 were $2.2 million, compared to $1.4 million for the first quarter of 2017, an increase of $0.8 million.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2018 was $8.8 million, or $0.35 per share, compared to a net loss of $4.4 million, or $0.20 per share, for the first quarter of 2017.
Recent Corporate Highlights:

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.
Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
In April 2018, Checkpoint presented preclinical data on BET inhibitor CK-103 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support its development as an anti-cancer agent alone and in combination with Checkpoint’s anti-PD-L1 antibody CK-301.

On May 10, 2018 Omeros Corporation (NASDAQ: OMER) reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2018, which include (Press release, Omeros, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348558 [SID1234526489]):

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1Q 2018 total and OMIDRIA revenues were $1.6 million, compared to $12.3 million in 1Q 2017; the decrease is the result of the scheduled expiration of OMIDRIA pass-through reimbursement status on January 1, 2018.
The Consolidated Appropriations Act, signed into law in March 2018, includes a provision granting a two-year pass-through extension, beginning on October 1, 2018, for a small number of drugs including OMIDRIA.
Net loss in 1Q 2018 was $30.1 million, or $0.62 per share. Non-cash expenses for 1Q 2018 were $4.3 million, or $0.09 per share. Overall decrease in cash, cash equivalents and short-term investments for the quarter was $10.9 million.
At March 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $72.8 million. An additional $45.0 million available under the company’s existing credit facility is expected to fund on May 18, 2018.
Patient enrollment began in the OMS721 Phase 3 clinical trial (known as ARTEMIS-IGAN) in patients with Immunoglobulin A (IgA) nephropathy.
OMS721 was granted breakthrough therapy designation for treatment of patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who have persistent TMA despite modification of immunosuppressive therapy.
Following recent interactions with FDA, Omeros believes that it has a clear path to approval for OMS721 in high-risk HSCT-TMA, intends to continue working closely with FDA to achieve this objective and has begun preparations to submit a Biologics License Application (BLA).
OMIDRIA was added to the Veterans Health Administration National Formulary in April 2018.
"During the first quarter of 2018, we made tremendous progress in our MASP-2 program," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We believe that we now have clear paths to accelerated approval for OMS721 in both stem-cell TMA and IgA nephropathy. With breakthrough therapy designations in both of these indications, we look forward to continuing to work closely with FDA and, for stem-cell TMA, we have initiated preparations for a BLA submission. Our PDE7 inhibitor OMS527 is poised to enter the clinic in mid-year and, in late 2019 through 2020, we expect to begin clinical trials for our MASP-3 antibody OMS906 and for our small-molecule MASP-2 inhibitors. A number of our GPCR programs are also moving toward the clinic, providing the potential for wholly new mechanisms for the treatment of a broad range of diseases and disorders, including cancers. With the Omeros team and the reinstatement of CMS separate payment for OMIDRIA, we believe that we will have the resources to deliver on the immense promise of these programs to benefit patients, many of whom have conditions for which there are no treatments."

First Quarter and Recent Developments

Developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) programs for the treatment of HSCT-TMA, IgA nephropathy, and atypical hemolytic uremic syndrome (aHUS), include:
Omeros announced in April 2018 that the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk HSCT-TMA, specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy designation for OMS721, which last year received the designation from FDA for the treatment of IgA nephropathy.
Omeros recently met with FDA to discuss requirements for approval of OMS721 in high-risk HSCT-TMA. Based on that meeting, Omeros believes that it has clear paths to both accelerated and full approval of OMS721 in this indication. In addition to the data provided to FDA, the Agency requested that the company further characterize the patients treated with OMS721 – all of whom had high-risk TMA – and compile and submit additional information on the historical control population for the purpose of further comparing outcomes across corresponding patients. FDA also requested an analysis plan to assess the company’s biomarker data. Should FDA grant OMS721 accelerated approval for the treatment of high-risk stem cell-TMA patients, the drug would be made commercially available for stem-cell patients with this highly lethal disorder. Concurrently, Omeros would conduct a confirmatory trial for subsequent full approval. Omeros intends to continue working closely with FDA as the company further compiles all required information with the objective of initiating a rolling BLA submission later this year. In Europe, the company is scheduling meetings with regulatory authorities to discuss plans for submission of an application for conditional marketing authorization for OMS721 in HSCT-TMA.
In February and April 2018, Omeros reported new results in patients with HSCT-TMA from the ongoing Phase 2 study. The estimated median survival for OMS721-treated patients was an order of magnitude greater than that for a matched historical control (p<0.0001). After study patients had reached an adequate duration of follow-up, further data analysis examined 100-day mortality, an important measure previously used as an approval endpoint in HSCT. That analysis also showed that OMS721-treated patients had improved survival relative to the historical control (53 percent vs 10 percent; p = 0.0002). Biomarkers of disease (i.e., mean platelet count and mean levels of lactate dehydrogenase and haptoglobin), demonstrated statistically significant improvement. Study patients also showed substantial improvement in red blood cell and platelet transfusion requirements.
In February 2018, the EMA granted OMS721 orphan drug designation in the treatment of IgA nephropathy. Enrollment in the Phase 3 clinical trial ARTEMIS-IGAN is ongoing.
Recent developments regarding OMIDRIA include:
In March 2018, the Consolidated Appropriations Act, 2018 (Consolidated Appropriations Act) was signed into law and included a two-year extension of pass-through reimbursement status for OMIDRIA and a small number of other drugs used during procedures performed on Medicare Part B fee-for-service patients. As a result, OMIDRIA will receive a reinstatement of separate payment beginning October 1, 2018 through September 30, 2020.
OMIDRIA was added to the Veterans Health Administration (VA) National Formulary in April 2018. With its addition to the formulary, the drug is now available in all VA facilities that perform ophthalmic procedures. The initial recommendation is that OMIDRIA be limited to use in high-risk patients as determined by each VA ophthalmic surgeon at his or her discretion.
In April 2018, Omeros announced that the results of four "real-world" clinical studies were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting held in Washington, D.C. The studies demonstrate significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.
In April 2018, the company’s credit facility with CRG was amended to eliminate the revenue and market capitalization covenants with respect to the twelve-month period ending on December 31, 2018 and to reduce the market capitalization threshold for future periods to three times the aggregate principal amount of loans outstanding (excluding any payment-in-kind loans) on the applicable determination date. Omeros issued five-year warrants to the lenders for up to 200,000 shares of the company’s common stock at an exercise price per share of $23.00, which represents approximately a 70-percent premium to the closing price of Omeros’ common stock at that time. In addition, the company has requested the $45.0 million currently available under the CRG credit facility and expects funding to occur on May 18, 2018.
Financial Results

For the quarter ended March 31, 2018, revenues were $1.6 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $12.3 million for the same period in 2017. On a sequential quarter-over-quarter basis, OMIDRIA revenues decreased $12.2 million, which is attributable to reduced ASC and hospital purchasing following the scheduled loss of pass-through reimbursement status as of January 1, 2018. As part of the Consolidated Appropriations Act, pass-through status for OMIDRIA was reinstated for a two-year period, effective October 1, 2018 through September 30, 2020.

Total costs and expenses for the three months ended March 31, 2018 were $29.3 million compared to $25.0 million for the same period in 2017. The increase in the current year quarter was primarily due to higher manufacturing scale-up costs for the OMS721 programs as Omeros continues to increase production capacity to meet anticipated clinical and commercial requirements as well as to incremental costs associated with initiating the OMS721 IgA nephropathy Phase 3 clinical trial.

For the three months ended March 31, 2018, Omeros reported a net loss of $30.1 million, or $0.62 per share, which included non-cash expenses of $4.3 million ($0.09 per share). In comparison, for the prior year’s first quarter Omeros reported a net loss of $15.1 million, or $0.34 per share including non-cash expenses of $4.4 million ($0.10 per share).

As of March 31, 2018, the company had $72.8 million of cash, cash equivalents and short-term investments available for operations and another $5.8 million in restricted investments. In addition, the company has requested $45.0 million currently available under the company’s existing credit facility and expects funding to occur on May 18, 2018.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 8579459. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 8579459.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On May 10, 2018 Medtronic plc (NYSE: MDT) reported that it will report financial results for its fourth quarter and fiscal year 2018 on Thursday, May 24, 2018. A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source (Press release, Medtronic, MAY 10, 2018, View Source/phoenix.zhtml?c=251324&p=RssLanding&cat=news&id=2348600 [SID1234526512]). The news release will include summary financial information for the company’s fourth quarter and fiscal year 2018, which ended on Friday, April 27, 2018.

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Medtronic will host a webcast at 7:00 a.m. CDT to discuss financial results for its fourth quarter and full fiscal year 2018. The webcast can be accessed at View Source on May 24, 2018.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal year 2019 first, second and third quarter financial results on Tuesday, August 21, 2018, Tuesday, November 20, 2018, and Tuesday, February 19, 2019, respectively. Medtronic also plans on hosting its biennial Institutional Investor & Analyst Day on Tuesday, June 5, 2018. Confirmation and additional details will be provided closer to the specific event.

On May 10, 2018 Exelixis, Inc. (Nasdaq:EXEL) reported that IMblaze370, the phase 3 pivotal trial of atezolizumab (TECENTRIQ), an anti-PDL1 antibody discovered and developed by Genentech, a member of the Roche Group, and cobimetinib (COTELLIC), an Exelixis-discovered MEK inhibitor, did not meet its primary endpoint (Press release, Exelixis, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348344 [SID1234526398]). Genentech, Exelixis’ collaborator and sponsor of the IMblaze370 trial, informed the company that the combination of atezolizumab and cobimetinib did not deliver an improvement in overall survival (OS) versus regorafenib. The IMblaze370 trial evaluated the combination in patients with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease had progressed or who were intolerant to at least two systemic chemotherapy regimens.

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The safety profile for the combination appeared consistent with the known safety profile of each individual medicine, and no new safety signals were identified with the combination. Genentech will further examine results from IMblaze370 and plans to present the data at an upcoming medical meeting.

"We are disappointed that the IMblaze370 trial did not reach a positive conclusion," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "Metastatic colorectal cancer is an aggressive and difficult-to-treat disease, and patients and clinicians would be well served by additional treatment options. We will continue to work with Genentech on the evaluation of cobimetinib’s potential in other tumor types, including in melanoma, in which there are two ongoing phase 3 pivotal trials. Separately, Exelixis remains focused on and committed to maximizing the potential of the cabozantinib franchise through our commercial activities and ongoing clinical development program evaluating the compound alone, or in combination with immune checkpoint inhibitors, across numerous tumor types."

Other ongoing late-stage clinical trials of cobimetinib include: IMspire150 TRILOGY, a fully enrolled study of cobimetinib, vemurafenib, and atezolizumab in previously untreated patients with BRAF V600-positive metastatic melanoma; and IMspire170, which is evaluating cobimetinib and atezolizumab in BRAF V600-wild type metastatic melanoma.

About the IMblaze370 Phase 3 Pivotal Trial

In early June 2016, shortly before the initial presentation of data from the phase 1b clinical trial of cobimetinib and atezolizumab at the 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Genentech initiated IMblaze370, a phase 3 pivotal trial of cobimetinib plus atezolizumab and atezolizumab monotherapy versus regorafenib in patients with locally advanced or metastatic CRC who had received at least two prior regimens of chemotherapy. The trial enrolled 363 patients who were randomized 2:1:1 to receive cobimetinib plus atezolizumab, atezolizumab alone, or regorafenib.

Patients in the combination arm received cobimetinib on days 1 to 21 plus atezolizumab on day 1 and day 15 in a 28-day cycle. Patients in the experimental monotherapy arm received atezolizumab on day 1 of each 21-day cycle. Patients in the control arm received regorafenib on days 1 to 21 in a 28-day cycle. All patients continued to receive study drug until clinical benefit was no longer observed.

The primary endpoint of IMblaze370 is OS; key secondary endpoints include progression-free survival, objective response rate, and duration of response. IMblaze370 completed enrollment in the first quarter of 2017. More information about IMblaze370 is available at www.clinicaltrials.gov.

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 now approved in multiple countries, including the U.S., European Union, Switzerland, Canada, Australia and Brazil, to treat specific forms of BRAF mutation-positive unresectable or metastatic melanoma, in combination with vemurafenib (ZELBORAF). The trade name for cobimetinib is COTELLIC. Cobimetinib is also the subject of a clinical development program aimed at evaluating its potential in combination with a variety of investigational and approved therapies in disease settings including metastatic melanoma, triple-negative breast cancer and colorectal carcinoma.

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

COTELLIC Indication

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.
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 changes
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.

Please see Full COTELLIC Prescribing Information and Patient Information for additional Important Safety Information at www.COTELLIC.com.

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