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Novocure (NVCR) overview updated February 2018
© Novocure 2018
forward-looking statements
2
This presentation contains certain forward-looking statements with respect to the business of Novocure and certain of its plans and objectives, including with
respect to the development and commercialization of its lead product candidate, Optune, for a number of oncology indications. These forward-looking statements
can be identified in this presentation by the fact that they do not relate only to historical or current facts. Forward-looking statements often use words “expect”,
“intend”, “anticipate”, “plan”, “may”, “should”, “would”, “could” or other words of similar meaning. These statements are based on assumptions and assessments made
by Novocure in light of industry experience and perception of historical trends, current conditions, expected future developments and other appropriate factors. By
their nature, forward-looking statements involve risk and uncertainty, and Novocure's performance and financial results could differ materially from those expressed
or implied in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and
uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2018, or in subsequent quarterly filings with the U.S.
Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those described in this presentation. Novocure assumes no obligation to update or correct the information contained in this
presentation, whether as a result of new information, future events or otherwise, except to the extent legally required.
The statements contained in this presentation are made as at the date of this presentation, unless some other time is specified in relation to them, and service of
this presentation shall not give rise to any implication that there has been no change in the facts set out in this presentation since such date. Nothing contained in
this presentation shall be deemed to be a forecast, projection or estimate of the future financial performance of Novocure, except where expressly stated.
As of the date of this presentation, Optune is only FDA-approved for the treatment of adults with supratentorial glioblastoma, or GBM, and its approval for other
indications is not certain. Novocure can provide no assurances regarding market acceptance of Optune or its successful commercialization, and can provide no
assurances regarding the company’s results of operations or financial condition in the future. This presentation is for informational purposes only and may not be
relied upon in connection with the purchase or sale of any security.
© Novocure 2018
INDICATIONS
• Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma
multiforme (GBM).
• Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma
following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care
chemotherapy.
• For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the
supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is
intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
CONTRAINDICATIONS
• Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement),
or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to
malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and
may possibly lead to tissue damage or render Optune ineffective.
• Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used
with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as
shock and respiratory failure.
Optune® indications for use and important safety information
3
© Novocure 2018
WARNINGS AND PRECAUTIONS
• Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by
Novocure (the device manufacturer).
• Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety
and effectiveness of Optune in these populations have not been established.
• The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea,
constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.
• The most common (≥10%) adverse events seen with Optune monotherapy were medical device site reaction and headache.
• The following adverse reactions were considered related to Optune when used as monotherapy: medical device site reaction,
headache, malaise, muscle twitching, fall and skin ulcer.
• Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness,
and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective.
• If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with
Optune treatment.
Optune® indications for use and important safety information
4
© Novocure 2018 5
a global oncology company with a proprietary platform GROWING COMMERCIAL BUSINESS SIGNIFICANT UPSIDE POTENTIAL
• More than 1,800 patients on therapy • 12 consecutive quarters of patient growth • $177 million trailing twelve month revenues
• Increase adoption and average reimbursement in GBM
• Advance clinical pipeline in five additional solid tumor indications
Information above as of December 31, 2017
© Novocure 2018
evolving treatment paradigms for solid tumor cancers
6
radiation pharmacological treatments
tumor treating fields (TTFields)
• Reduces size of a tumor prior to initiation of additional therapies
• Invasive to patient
• Unable to kill microscopic disease
• Kills cells when delivered at high doses
• Injures healthy tissues as well as cancer cells
• Numerous potentially toxic side effects
• Includes chemotherapy, targeted therapies and immuno-oncology
• Many treatments target specific patient subgroups
• Frequently accompanied by numerous side effects
• Electric fields tuned to specific frequencies
• Disrupts solid tumor cancer cell division
• Mild side effect profile with no known cumulative toxicity
USED ALONE OR IN COMBINATION TO TREAT SOLID TUMORS
surgery
© Novocure 2018
we can leverage physics to fight cancer
7
AN ELECTRIC FIELD EXERTS FORCES ON CHARGED OBJECTS
TUMOR TREATING FIELDS USES ELECTRIC FIELDS TO DISRUPT CELL DIVISION
+ + + + + + + + + + + + + + +
- - - - - - - - - - - - - - -
+ +
- MISALIGNED
TUBULINS INTERFERE WITH FORMATION OF
MITOTIC SPINDLE
MISALIGNED SEPTINS
INTERFERE WITH FORMATION OF
CONTRACTILE RING
ALTERNATING ELECTRIC FIELDS DISRUPT CANCER
CELL DIVISION
CANCER CELL DEATH
TUMOR TREATING FIELDS DESCRIBES ELECTRIC FIELDS THAT ALTERNATE 100,000 TO 300,000 TIMES PER SECOND TO TARGET CANCER CELLS
© Novocure 2018
broad applicability to solid tumors
8
INDICATIONS IN-VITRO EVIDENCE IN-VIVO EVIDENCE FIRST IN HUMAN EVIDENCE
Glioblastoma
Malignant melanoma
Non-small cell lung cancer
Pancreatic cancer
Breast cancer
Mesothelioma
Ovarian carcinoma
Renal adenocarcinoma
Cervical cancer
Colorectal carcinoma
Ependymoma
Gastric adenocarcinoma
Gliosarcoma
Hepatocellular carcinoma
Medulloblastoma
Meningioma
Small cell lung cancer
Urinary transitional cell carcinoma
© Novocure 2018
proven superior long-term survival with Optune® plus temozolomide in GBM1
9
Optune® + TMZ (n=466) TMZ alone (n=229)
0 6 12 48 54 60 18 24 30 36 42
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0.9
1.0
Pro
bab
ility
of
surv
ival
Overall Survival (months)
Median OS from randomization (months)
20.9 16.0
Stratified log-rank p=0.00006
HR (95% CI) 0.63 (0.53-0.76)
Median OS from diagnosis (months)
24.5 19.8 24.5
Intent-to-treat population1
20.9 16.0
19.8 43%
13% 31%
5%
TMZ alone
TMZ alone
Optune® + TMZ
Optune® + TMZ
p=0.001
p=0.0037
1. Stupp R, Taillibert S, Kanner A, et al. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017;318(23):2306–2316.
© Novocure 2018
73%
43%
26% 20%
13%
65%
31%
16% 8% 5% 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5
Surv
ival
rat
e (%
)
Year from randomization
Optune® + TMZ (n=466)
TMZ alone (n=229)
Optune® plus TMZ consistently sustained superior rates of survival
10
1. Stupp R, Taillibert S, Kanner A, et al. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017;318(23):2306–2316.
FIVE-YEAR SURVIVAL INTENT-TO-TREAT ANALYSIS1
p=0.029
p=0.001
p=0.004 p=0.0002
p=0.004
© Novocure 2018
patients with increased compliance had increased survival benefit
11
86%
55%
29% 29% 29%
65%
31%
16% 8% 5%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5
Surv
ival
rat
e (%
)
Year from randomization
Optune > 90% compliance + temozolomide (n=43)
temozolomide alone (n=229)
1. Ram Z, Kim CY, Nicholas GA and Toms S on behalf of EF-14 investigators. Compliance and treatment duration predict survival in a phase 3 EF-14 trial of Tumor Treating Fields with temozolomide in patients with newly diagnosed glioblastoma. Presented at: 2017 Society for Neuro Oncology; November 16-19, 2017; San Francisco, CA. Oral presentation ACTR-27.
FIVE-YEAR SURVIVAL ANALYSIS IN MOST COMPLIANT PATIENTS (>90%)1
© Novocure 2018
global commercial presence • ADULT PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED GBM
ADULT PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED GBM
12
JAPAN
2 sales force colleagues
UNITED STATES
49 sales force colleagues
JAPAN
163 certified centers
EMEA
245 certified centers
UNITED STATES
714 certified centers
certified centers
sales force colleagues
EMEA
10 sales force colleagues
global active markets as of December 31, 2017
© Novocure 2018
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017
successful commercial launch in GBM
13
active patients at period end
U.S. active patients EMEA and Japan active patients
372 425 469
605
797 891
985 1,091
1,266
1,460
1,683
12 CONSECUTIVE QUARTERS OF ACTIVE PATIENT GROWTH SINCE INITIAL PRESENTATION OF EF-14 DATA
7,000+ PATIENTS TREATED TO DATE GLOBALLY
1,834
© Novocure 2018
ongoing clinical trials
14
PRECLINICAL PHASE II
PILOT PHASE III PIVOTAL MILESTONES
Brain metastases METIS trial last patient in 2019 with final data collection in 2020
Non-small cell lung cancer LUNAR trial last patient in 2019 with final data collection in 2021
Pancreatic cancer PANOVA 3 trial last patient in 2020 with final data collection in 2022
Ovarian cancer phase three pivotal trial first patient in 2H 2018
Mesothelioma STELLAR trial final data collection in 1H 2018
Trial complete Trial ongoing
© Novocure 2018
addressing large market segments with significant unmet medical needs
15
BRAIN METASTASES
NON-SMALL CELL LUNG CANCER
PANCREATIC CANCER
OVARIAN CANCER MESOTHELIOMA
223,000 CASES DIAGNOSED
ANNUALLY IN TARGET MARKETS3-5
8% FIVE YEAR SURVIVAL3
659,000 CASES DIAGNOSED
ANNUALLY IN TARGET MARKETS3-5
24% FIVE YEAR SURVIVAL3
100,000 CASES DIAGNOSED
ANNUALLY IN TARGET MARKETS3-5
47% FIVE YEAR SURVIVAL3
13,000 CASES DIAGNOSED
ANNUALLY IN TARGET MARKETS3,6-7
9% FIVE YEAR SURVIVAL3
258,000 CASES DIAGNOSED
ANNUALLY IN TARGET MARKETS1
~25% OF NSCLC PATIENTS DEVELOP BRAIN METS2
1. Goetz P, Ebinu JO, Roberge D, Zadeh G. Current Standards in the Management of Cerebral Metastases. Intl J of Surg Onc. 2012;2012:493426. doi:10.1155/2012/493426. 2. Owen S, Souhami L. The management of brain metastases in non-small cell lung cancer. Frontiers in Oncology. 2014;4:248. doi:10.3389/fonc.2014.00248. 3. Howlader N, Noone AM, et al. SEER Cancer Statistics Review, 1975-2014, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2014/, based on November 2016 SEER data submission, posted to SEER web site, April 2017. 4. Ferlay J, Steliarova-Foucher E, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. 5. WHO (2016) GLOBOCAN 2012: Estimated Cancer Incidence, Mortality, and Prevalence Worldwide in 2012, Lyon, France (accessed January 2018). 6. Peto J, Decarli A, La Vecchia C, Levi F, Negri E. The European mesothelioma epidemic. Br J Cancer 1999;79:666 –72. doi: 10.1038/sj.bjc.6690105. 7. Robinson B.M. Malignant pleural mesothelioma: an epidemiological perspective. Ann Cardiothorac Surg. 2012; 1(4): 491–496. doi: 10.3978/j.issn.2225-319X.2012.11.04.
© Novocure 2018
demonstrated financial performance
16
global net revenues (USD in thousands)
$5,208 $6,543 $8,953
$12,383 $13,053
$17,919 $21,674
$30,242
U.S. net revenues EMEA and Japan net revenues
$34,880 $38,376
$50,109
77% Q4 2017 VERSUS Q4 2016 YEAR-OVER-YEAR REVENUE GROWTH
$183.3 MILLION IN CASH AND SHORT-TERM EQUIVALENTS AS OF DECEMBER 31, 2017
$33,087 $82,888
FY 2015 FY 2016
$177,026
FY 2017
$53,661
$0
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017
© Novocure 2018
q4 2017 selected financial highlights
17
U.S. DOLLARS IN THOUSANDS
Q4 2017 Q4 2016 % GROWTH
Net revenues $ 53,661 $ 30,242 77% Cost of revenues 15,640 10,973 43%
Gross profit 38,021 19,269 97%
Research, development and clinical trials 10,048 8,471 19% Sales and marketing 16,025 15,678 2% General and administrative 16,454 12,997 27% Total operating costs and expenses 42,527 37,146 14%
Operating income (loss) (4,506 ) (17,877 ) 75% Financial expenses, net 2,384 2,854 -16%
Income (loss) before income taxes (6,890 ) (20,731 ) 67% Income tax expense 4,055 1,437 182%
Net income (loss) $ (10,945 ) $ (22,168 ) 51%
Cash and cash equivalents $ 78,592 $ 99,780 Short-term investments 104,719 119,854
ESTIMATE THAT GLOBAL NET REVENUES WILL BE APPROXIMATELY
45% OF GLOBAL GROSS BILLINGS IN 2018
© Novocure 2018
• Launch Tumor Treating Fields platform for additional indications in
large addressable markets
• Brain metastases from non-small cell lung cancer
• Non-small cell lung cancer
• Pancreatic cancer
• Ovarian cancer
• Drive commercial adoption of Optune within GBM
• Expand coverage for GBM patients in currently active markets and
establish access for GBM patients in new markets
• Progress mesothelioma towards commercialization
• Advance the clinical pipeline in multiple solid tumor indications
• Grow annual revenues while improving SG&A operating leverage
near-term opportunity
2018- 2021
long term value creation beyond 2018
18
long-term opportunity
2021+
commercial appendix
© Novocure 2018
direct-to-patient distribution model
20
PHYSICIAN SENDS
PRESCRIPTION
ORDER TO
NOVOCURE
PHYSICIAN OR
NOVOCURE USES
NOVOTAL SYSTEM TO
CREATE ARRAY
PLACEMENT MAP
NOVOCURE
DELIVERS OPTUNE
AND TRAINS
PATIENT/FAMILY
NOVOCURE
PROVIDES 24/7
TECH SUPPORT AND
SUPPLIES
TRANSDUCER
ARRAYS
NOVOCURE BILLS
THIRD-PARTY
PAYER AND
PATIENT1 FOR EACH
MONTH OF
THERAPY
PHYSICIAN SEES
PATIENT FOR
REGULAR
COMPLIANCE
MONITORING AND
FOLLOW-UP
APPOINTMENTS
NOVOCURE
Novocure distributes product through hospitals in Japan. 1. Subject to patient assistance programs.
© Novocure 2018
established U.S. commercial market access
21
>210 MILLION COVERED LIVES
IN THE U.S. AS OF DECEMBER 31, 2017
>178 MILLION CONTRACTED LIVES IN THE U.S. AS OF DECEMBER 31, 2017
1. U.S. population insured with employers, non-group insurance or Medicare Advantage plans
2. Appealing Medicare fee-for-service denials, impacting 20-25% of U.S. active patients
96%
OF AMERICANS WITH PRIVATE HEALTH INSURANCE1,2
NOW HAVE POSITIVE COVERAGE OF OPTUNE
© Novocure 2018
expanding global commercial market access
22
MARKET STATUS REIMBURSEMENT STATUS GBM MARKET SIZE
ESTIMATION
POSITIVE NATIONAL REIMBURSEMENT DECISIONS
Japan Commercial launch underway
National reimbursement contract signed in Q4 2017 1,500 annual cases diagnosed
Austria Commercial launch underway
National reimbursement contract signed in Q3 2017 280 annual cases diagnosed
ONGOING DIALOGUES WITH GOVERNMENT PAYERS IN THE UNITED STATES, GERMANY, SWITZERLAND AND ISRAEL
United States No material payments from Medicare to date
In active discussions with CMS administration 12,500 annual cases diagnosed
Germany Receive reimbursement on case-by-case basis
Pathway for national reimbursement established Q3 2017 via G-BA budgeted clinical trial (expected to begin 2H 2018)
3,600 annual cases diagnosed
Switzerland Single-payer system Pursuing national reimbursement 300 annual cases diagnosed
Israel No material payments to date
Pursuing national reimbursement 280 annual cases diagnosed
clinical appendix
© Novocure 2018
TTFields are frequency-tuned to cell size to maximize effects on mitosis
24
Normal Intestine
~50 kHz
Pancreatic Cancer
150 kHz
NSCLC
150 kHz
Ovarian Cancer
200 kHz
GBM
200 kHz
EFFECTS ON CELLS ARE FREQUENCY SPECIFIC AND INVERSELY RELATED TO CELL SIZE
© Novocure 2018
transducer array placement
25
abdominal array placement
torso array placement
pelvic array placement
© Novocure 2018
compliance effects on overall survival1 EF-14 TRIAL IN NEWLY DIAGNOSED GLIOBLASTOMA
26
• A trend in favor of longer overall
survival was seen with higher
compliance
• A threshold value of 50% average
monthly compliance with Tumor
Treating Fields was needed to show
an extension of overall survival (HR
0.67, 95% CI 0.45–0.99) compared
to temozolomide alone
• Both progression-free survival and
overall survival were extended with
increased compliance beyond 50%
1. Ram Z, Kim CY, Nicholas GA and Toms S on behalf of EF-14 investigators. Compliance and treatment duration predict survival in a phase 3 EF-14 trial of Tumor Treating Fields with temozolomide in patients with newly diagnosed glioblastoma. Presented at: 2017 Society for Neuro Oncology; November 16-19, 2017; San Francisco, CA. Oral presentation ACTR-27.
© Novocure 2018
METIS phase 3 pivotal trial initiated in 2016 BRAIN METASTASES FROM NON-SMALL CELL LUNG CANCER
27
A prospective, randomized controlled, multicenter trial testing efficacy, safety and neurocognitive outcomes of TTFields at 150 kHz following stereotactic radiosurgery for 1-10 brain metastases from non-small cell lung cancer
• 270 patients internationally, randomized 1:1 (TTFields vs supportive care) • Last patient enrollment expected in 2019, twelve month follow-up after final patient enrollment • Primary endpoint — time to first intracranial progression • Secondary endpoints include neurocognitive failure, overall survival, radiological response rate
Novocure, Ltd. Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 Jan]. Available from: https://clinicaltrials.gov/ct2/show/NCT02831959. NLM Identifier: NCT02831959
screening and baseline evaluation
ran
do
miz
atio
n 1
:1
stereotactic radiosurgery ttfields MRI q2m until progression
stereotactic radiosurgery supportive care MRI q2m until progression
© Novocure 2018
phase 2 pilot EF-15 trial SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER
28
A prospective, open label, single-arm, non-randomized, multicenter study testing safety and preliminary efficacy of TTFields at 150 kHz together with pemetrexed in pretreated patients with locally advanced and/or metastatic non-small cell lung cancer versus historical controls
• 42 patients in Switzerland with locally advanced and/or metastatic non-small cell lung cancer • Last patient enrolled May 2011 with six month follow-up, data published in Lung Cancer in 2013
Novocure, Ltd. NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 Jan]. Available from: https://clinicaltrials.gov/ct2/show/NCT00749346. NLM Identifier: NCT00749346 1. Pless M., Droege C., von Moos R., et al. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-50. doi: 10.1016/j.lungcan.2013.06.025 2. Hanna N., Shepherd F.A., Fossella F.V., et al. Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy. J Clin Oncol. 2004 May 1;22(9):1589-97. doi: 10.1200/JCO.2004.08.163
EFFICACY ENDPOINTS
TTFIELDS WITH PEMETREXED1
PEMETREXED-ALONE HISTORICAL RESULTS2
Median in-field PFS 6.5 months n/a
Median PFS 5 months 2.9 months
Median OS 13.8 months 8.3 months
One-year survival rate 57% 29.7%
© Novocure 2018
LUNAR phase 3 pivotal trial initiated in 2017 SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER
29
A prospective, randomized controlled, multicenter trial testing efficacy and safety of TTFields at 150 kHz in combination with docetaxel or immune checkpoint inhibitors for stage IV NSCLC patients following progression while on or after platinum based treatment
• 534 patients (TTFields plus docetaxel or immune checkpoint inhibitors vs docetaxel or immune checkpoint inhibitors alone)
• Last patient enrollment expected in 2019, eighteen month follow-up after final patient enrollment • Primary endpoint – overall survival (OS) (superiority) • Secondary endpoints –
• OS of TTFields + docetaxel vs docetaxel alone (superiority) • OS of TTFields + immune checkpoint inhibitors vs immune checkpoint inhibitors alone (superiority) • OS of TTFields + docetaxel vs immune checkpoint inhibitors alone (non-inferiority)
Novocure, Ltd. Effect of Tumor Treating Fields (TTFields) (150 kHz) as Second Line Treatment of Non-small Cell Lung Cancer (NSCLC) in Combination With PD-1 Inhibitors or Docetaxel (LUNAR) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 Jan]. Available from: https://clinicaltrials.gov/ct2/show/NCT02973789. NLM Identifier: NCT02973789
progression on or after platinum-based therapy
screening and baseline
evaluation
ran
do
miz
atio
n
1:1
ttfields + immune checkpoint
inhibitor/docetaxel
CT q6w until progression
three post-progression
follow-up visits
survival follow up
immune checkpoint inhibitor/docetaxel
CT q6w until progression
three post-progression
follow-up visits
survival follow up
© Novocure 2018
phase 2 pilot PANOVA trial LOCALLY ADVANCED AND METASTATIC PANCREATIC CANCER
30
A prospective, open label, single-arm, non-randomized, multicenter study testing feasibility, safety and preliminary efficacy of TTFields at 150 kHz together with gemcitabine or gemcitabine plus nab-paclitaxel in patients with advanced pancreatic cancer versus historical controls
• 40 patients (2 cohorts of 20 patients) in Europe with advanced pancreatic cancer • Last patient enrolled May 2016 with six month follow-up
Novocure, Ltd. Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 Jan]. Available from: https://clinicaltrials.gov/ct2/show/NCT01971281. NLM Identifier: NCT01971281 1. Rivera F., et al. PANOVA: A pilot study of TTFields concomitant with gemcitabine for front-line therapy of advanced pancreatic adenocarcinoma. In: 2016 Gastrointestinal Cancers Symposium; 2016 Jan 21-23; San Francisco, CA. Alexandria (VA): ASCO; 2016. Abstract 682. 2. Von Hoff D.D., Ervin T., Arena F.P., et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369 3. Benavides M. et.al. PANOVA: A phase II study of TTFields (150kHz) concomitant with standard chemotherapy for front line therapy of advanced pancreatic adenocarcinoma In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2017 Apr
1-5; Washington, DC. Philadelphia (PA): AACR; 2017. Abstract CT130.
EFFICACY ENDPOINTS
TTFIELDS WITH GEMCITABINE1
GEMCITABINE-ALONE HISTORICAL RESULTS2
TTFIELDS WITH NAB-PACLITAXEL + GEMCITABINE3
NAB-PACLITAXEL + GEMCITABINE
HISTORICAL RESULTS2
Median PFS 8.3 months 3.7 months 12.7 months 5.5 months
Median OS 14.9 months 6.7 months Not yet reached 8.5 months
One-year survival rate 55% 22% 72% 35%
Partial response rate 30% 7% 40% 23%
Stable disease 30% 28% 47% 27%
© Novocure 2018
PANOVA 3 pivotal trial initiated in 2017 LOCALLY ADVANCED PANCREATIC CANCER
31
A prospective, randomized controlled, multicenter trial testing efficacy and safety of TTFields at 150 kHz together with nab-paclitaxel plus gemcitabine as first-line treatment in patients with unresectable, locally advanced pancreatic cancer
• 556 patients internationally, randomized 1:1 (TTFields plus nab-paclitaxel plus gemcitabine vs nab-paclitaxel plus gemcitabine alone)
• Last patient enrollment expected in 2020, eighteen month follow-up after final patient enrollment • Primary endpoint – overall survival (OS) • Secondary endpoints include PFS, objective response rate, rate of resectability, quality of life
screening and baseline evaluation
ran
do
miz
atio
n 1
:1
ttfields + nab-paclitaxel + gemcitabine
CT q8w until progression
second line chemotherapy survival follow up
nab-paclitaxel + gemcitabine
CT q8w until progression
second line chemotherapy survival follow up
Novocure, Ltd. Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 Jan]. Available from: https://clinicaltrials.gov/ct2/show/NCT03377491. NLM Identifier: NCT03377491
© Novocure 2018
phase 2 pilot INNOVATE trial RECURRENT OVARIAN CANCER
32
A prospective, open label, single-arm, non-randomized, multicenter study testing feasibility, safety, toxicity and preliminary efficacy of TTFields at 200 kHz together with weekly paclitaxel in patients with recurrent ovarian cancer versus historical controls
• 30 patients in Europe with recurrent ovarian cancer • Last patient enrolled May 2016 with six month follow-up
Novocure, Ltd. Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 Jan]. Available from: https://clinicaltrials.gov/ct2/show/NCT02244502. NLM Identifier: NCT02244502 1. Vergote I., et.al. INNOVATE: a phase II study of TTFields (200 kHz) concomitant with weekly paclitaxel for recurrent ovarian carcinoma. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2017 Apr 1-5; Washington, DC. Philadelphia
(PA): AACR; 2017. Abstract CT135. 2. Poveda A.M., Selle F., Hiplert F. et al. Bevacizumab Combined With Weekly Paclitaxel, Pegylated Liposomal Doxorubicin, or Topotecan in Platinum-Resistant Recurrent Ovarian Cancer: Analysis by Chemotherapy Cohort of the Randomized Phase III AURELIA Trial. J of Clin Onc.
2015 Nov 10;33(32):3836-8. doi: 10.1200/JCO.2015.63.1408. * Median PFS reflects the weekly paclitaxel subgroup; Median PFS for all chemotherapies was 3.4 months
EFFICACY ENDPOINTS
TTFIELDS WITH PACLITAXEL1
PACLITAXEL-ALONE HISTORICAL RESULTS2
Median PFS 8.9 months 3.9 months*
Median OS Not yet reached 13.2 months
One-year survival rate 61%
© Novocure 2018
phase 2 pilot STELLAR trial FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA
33
A prospective, open label, single-arm, non-randomized, multicenter study testing safety and preliminary efficacy of TTFields at 150 kHz together with pemetrexed and cisplatin or carboplatin in patients with previously untreated malignant pleural mesothelioma versus historical controls
• 80 patients in Europe with unresectable, previously untreated malignant mesothelioma • Last patient enrolled March 2017 with twelve month follow-up, interim data presented at IASLC 2016
Novocure, Ltd. Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 Jan]. Available from: https://clinicaltrials.gov/ct2/show/NCT02397928. NLM Identifier: NCT02397928 1. Cerasoli, G.L. International Association for the Study of Lung Cancer. OA22.01 – STELLAR – Interim Results of a Phase 2 Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma. Oral Session: Novel Trials and Biomarkers in Malignant Pleural
Mesothelioma. Wednesday, Dec. 7, 2016, 2:20 p.m. CET 2. Vogelzang N.J., Rusthoven J.J., Symanowski J., et al. Phase III Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Alone in Patients With Malignant Pleural Mesothelioma J Clin Oncol. 2003 Jul 15;21(14):2636–44. doi: 10.1200/JCO.2003.11.136
EFFICACY ENDPOINTS
TTFIELDS WITH PEMETREXED AND
CISPLATIN OR CARBOPLATIN1
PEMETREXED AND CISPLATIN-ALONE
HISTORICAL RESULTS2
Median PFS 7.3 months 5.7 months
Median OS Not yet reached 12.1 months
One-year survival rate 79.7% 50.3%
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