Novocure (NVCR) overview - updated July 2018
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Novocure (NVCR) overview updated July 2018
forward-looking statements
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 2
Optune® indications for use and
important safety information
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.
© Novocure 2018 3
Optune® indications for use and
important safety information
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.
© Novocure 2018 4
a global oncology company
with a proprietary platform
GROWING COMMERCIAL BUSINESS SIGNIFICANT UPSIDE POTENTIAL
• More than 2,100 patients on therapy • Increase adoption and average
• 14 consecutive quarters of patient growth reimbursement in GBM
• $217 million trailing twelve month revenues • Advance clinical pipeline in five additional
solid tumor indications
Information above as of June 30, 2018
© Novocure 2018 5
we can leverage physics to fight cancer
AN ELECTRIC FIELD TUMOR TREATING FIELDS USES ELECTRIC FIELDS
EXERTS FORCES ON CHARGED OBJECTS TO DISRUPT CELL DIVISION
+ + + + + + + + + + + + + + +
-
+ MISALIGNED MISALIGNED
+ TUBULINS ALTERNATING SEPTINS
INTERFERE WITH ELECTRIC FIELDS INTERFERE WITH
FORMATION OF DISRUPT CANCER FORMATION OF
MITOTIC SPINDLE CELL DIVISION CONTRACTILE RING
- - - - - - - - - - - - - - -
TUMOR TREATING FIELDS
DESCRIBES ELECTRIC FIELDS
THAT ALTERNATE 100,000 TO
300,000 TIMES PER SECOND
TO TARGET CANCER CELLS
CANCER CELL DEATH
© Novocure 2018 6
broad applicability to solid tumors
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 7
proven superior long-term survival with
Optune® plus temozolomide in GBM1
1.0 Median OS from
Intent-to-treat population1 20.9 16.0
16.0
0.9
randomization (months)
Optune® + TMZ (n=466)
0.8 TMZ alone (n=229) Stratified log-rank p=0.00006
Probability of survival
0.7 HR (95% CI) 0.63 (0.53-0.76)
Optune® + TMZ
Median OS from 24.5 19.8
0.6 43% diagnosis (months)
24.5 19.8
0.5
p=0.001
0.4 Optune® + TMZ
TMZ alone
0.3 13%
31%
0.2 p=0.0037
0.1
1. Stupp R, Taillibert S, Kanner A, et al. Effect of Tumor-
0 6 12 18 24 30 36 42 48 54 60
5% Treating Fields Plus Maintenance Temozolomide vs
Maintenance Temozolomide Alone on Survival in
0.0
Patients With Glioblastoma: A Randomized Clinical
Overall Survival (months) TMZ alone Trial. JAMA. 2017;318(23):2306–2316.
© Novocure 2018 8
Optune® plus temozolomide consistently
sustained superior rates of survival1
FIVE-YEAR SURVIVAL INTENT-TO-TREAT ANALYSIS
100%
p=0.029
90% Optune® + TMZ (n=466)
80% TMZ alone (n=229)
70%
73%
Survival rate (%)
60% p=0.001
65%
50%
40% p=0.004
43% p=0.0002
30%
31% p=0.004
20% 26%
20%
10% 16%
8% 13%
5%
0%
1 2 3 4 5
Year from randomization
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 9
patients with increased compliance
had increased survival benefit1
• 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 10five-year survival analysis in
most compliant patients (>90%)1
100%
Optune > 90% compliance + temozolomide (n=43)
90%
temozolomide alone (n=229)
80% 86%
70%
Survival rate (%)
60% 65%
50% 55%
40%
30%
31% 29% 29% 29%
20%
10% 16%
8% 5%
0%
1 2 3 4 5
Year from randomization
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 11NCCN guidelines updated in March 2018
The updated NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines®) for Central Nervous
System Cancers now include alternating electric field
therapy (Optune) in combination with temozolomide
(TMZ) following maximal safe resection and standard
brain radiation therapy with concurrent TMZ as
Category 1 recommended treatment option for
patients with newly diagnosed supratentorial
glioblastoma (GBM) and good performance status.*
There is uniform NCCN consensus for this
recommendation based on high-level evidence
(Category 1).
* The NCCN defines good performance as Karnofsky Performance Score (KPS) ≥60. The trial for which the IFU is based used an eligibility criteria of KPS ≥70.
© Novocure 2018 12ADULT PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED GBM
global commercial presence
global active markets as of June 30, 2018
EMEA
UNITED STATES
EMEA
10
806 266
sales force
colleagues
certified centers
certified centers JAPAN
UNITED STATES
174
51 certified centers
sales force
colleagues JAPAN
4 certified centers
sales force sales force colleagues
colleagues
© Novocure 2018 13steady prescription growth in newly diagnosed GBM
1000 KEY TAKEAWAYS
900
• ~75% of Q2 prescriptions were
800 ~75%
of total
written for patients with newly
700
diagnosed GBM
600 ~65%
500 of total • We believe growth is a sign of
400 increasing physician
300
~50%
confidence and belief
200 of total
100
0
Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018
Prescriptions for newly diagnosed GBM
© Novocure 2018 14continued growth in active patients
active patients at period end
2500
2,169
14
CONSECUTIVE QUARTERS
2,009
2000 OF ACTIVE PATIENT GROWTH
1,834 SINCE INITIAL PRESENTATION
1,683 OF EF-14 DATA
1500
1,460
1,266
8,000+
1,091
985
1000 891
797
605
425 469
500 372 PATIENTS TREATED
TO DATE GLOBALLY
0
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018
U.S. active patients EMEA active patients Japan active patients
© Novocure 2018 15advancing clinical pipeline
PHASE II PHASE III
PRECLINICAL PILOT 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 open in 2H 2018
Mesothelioma STELLAR trial data presentation in 2H 2018
Liver cancer HEPANOVA trial first patient in 2H 2018
Trial ongoing Trial complete
© Novocure 2018 16demonstrated financial performance
global net revenues (USD in thousands)
60%
$70,000
$61,514
$60,000
$53,661
$52,125
$50,109
$50,000
Q2 2018 VERSUS Q2 2017
YEAR-OVER-YEAR
$40,000 $38,376
$34,880 REVENUE GROWTH
$30,242
$30,000
$21,674
$20,000 $17,919
$219
$12,383 $13,053
$10,000 $8,953
$5,208 $6,543
$0
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018
MILLION IN CASH AND
$33,087 $82,888 $177,026 SHORT-TERM EQUIVALENTS
AS OF JUNE 30, 2018
FY 2015 FY 2016 FY 2017
U.S. net revenues EMEA net revenues Japan net revenues
© Novocure 2018 17q2 2018 selected financial highlights
% Q2 2018 Q2 2017 %
U.S. DOLLARS IN THOUSANDS Q2 2018 Q2 2017 CHANGE YTD YTD CHANGE
Net revenues $ 61,514 $ 38,376 60% $ 113,639 $ 73,256 55%
Cost of revenues 19,833 13,152 51% 38,071 24,816 53%
Gross profit 41,681 25,224 65% 75,568 48,440 56%
Research, development and clinical trials 11,362 9,371 21% 22,466 18,782 20%
Sales and marketing 19,196 16,360 17% 37,331 31,116 20%
General and administrative 18,208 15,023 21% 35,533 27,445 29%
Total operating costs and expenses 48,766 40,754 20% 95,330 77,343 23%
Operating income (loss) (7,085 ) (15,530) 54% (19,762 ) (28,903) 32%
Financial expenses, net 2,860 2,183 31% 7,713 4,629 67%
Income (loss) before income taxes (9,945) (17,713) 44% (27,475) (33,532) 18%
Income taxes 5,565 3,461 61% 8,759 5,687 54%
Net income (loss) $ (15,510) $ (21,174) 27% $ (36,234) $ (39,219) 8%
Cash and cash equivalents $ 114,456 $ 80,190 $ 114,456 $ 80,190
Short-term investments 104,499 104,186 104,499 104,186
© Novocure 2018 18long term value creation beyond 2018
near-term • Drive commercial adoption of Optune within GBM
opportunity • Expand coverage for GBM patients in currently active markets and
2018- establish access for GBM patients in new markets
• Progress mesothelioma towards commercialization
2021 • Advance the clinical pipeline in multiple solid tumor indications
• Grow annual revenues while improving SG&A operating leverage
• Launch Tumor Treating Fields platform for additional indications in
long-term large addressable markets
opportunity o Brain metastases from non-small cell lung cancer
2021+ o Non-small cell lung cancer
o Pancreatic cancer
o Ovarian cancer
© Novocure 2018 19commercial appendix
direct-to-patient distribution model*
PHYSICIAN SENDS PHYSICIAN OR NOVOCURE NOVOCURE NOVOCURE BILLS PHYSICIAN SEES
PRESCRIPTION NOVOCURE USES DELIVERS OPTUNE PROVIDES 24/7 THIRD-PARTY PATIENT FOR
ORDER TO NOVOTAL SYSTEM TO AND TRAINS TECH SUPPORT AND PAYER AND REGULAR
NOVOCURE CREATE ARRAY PATIENT/FAMILY SUPPLIES PATIENT1 FOR EACH COMPLIANCE
PLACEMENT MAP TRANSDUCER MONTH OF MONITORING AND
ARRAYS THERAPY FOLLOW-UP
APPOINTMENTS
NOVOCURE
* Novocure distributes product through hospitals in Japan.
1. Subject to patient assistance programs.
© Novocure 2018 21established U.S. commercial market access
>217 MILLION COVERED LIVES
IN THE U.S. AS OF
96%
MARCH 31, 2018
>187 MILLION CONTRACTED LIVES
IN THE U.S. AS OF
MARCH 31, 2018
1. U.S. population insured with employers, non-
OF AMERICANS WITH PRIVATE HEALTH INSURANCE1,2 group insurance or Medicare Advantage plans
NOW HAVE POSITIVE COVERAGE OF OPTUNE 2. Appealing Medicare fee-for-service denials,
impacting 20-25% of U.S. active patients
© Novocure 2018 22expanding global commercial market access
GBM MARKET SIZE
MARKET STATUS REIMBURSEMENT STATUS ESTIMATION
POSITIVE NATIONAL REIMBURSEMENT DECISIONS
Commercial launch 1,500 annual cases
Japan National reimbursement contract signed in Q4 2017
in Q1 2018 diagnosed
Commercial launch 340 annual cases
Austria National reimbursement contract signed in Q3 2017
in Q4 2017 diagnosed
ONGOING DIALOGUES WITH GOVERNMENT PAYERS IN THE UNITED STATES, GERMANY, SWITZERLAND AND ISRAEL
No material payments from 12,500 annual
United States In active discussions with CMS administration
Medicare to date cases diagnosed
Receive reimbursement on Pathway for national reimbursement established Q3 2017 3,600 annual cases
Germany
case-by-case basis via G-BA budgeted clinical trial (expected to begin 2H 2018) diagnosed
330 annual cases
Switzerland Single-payer system Pursuing national reimbursement
diagnosed
No material payments 325 annual cases
Israel Pursuing national reimbursement
to date diagnosed
© Novocure 2018 23clinical appendix
evolving treatment paradigms
for solid tumor cancers
USED ALONE OR IN COMBINATION TO TREAT SOLID TUMORS
surgery radiation pharmacological tumor treating fields
treatments (TTFields)
• Reduces size of a • Kills cells when • Includes chemotherapy, • Electric fields tuned to
tumor prior to delivered at high targeted therapies specific frequencies
initiation of doses and immuno-oncology • Disrupts solid tumor
additional • Injures healthy • Many treatments cancer cell division
therapies tissues as well as target specific • Mild side effect profile
• Invasive to patient cancer cells patient subgroups with no known
• Unable to kill • Numerous • Frequently cumulative toxicity
microscopic potentially toxic accompanied by
disease side effects numerous side effects
© Novocure 2018 25TTFields are frequency-tuned to cell size
to maximize effects on mitosis
EFFECTS ON CELLS ARE FREQUENCY SPECIFIC AND INVERSELY RELATED TO CELL SIZE
Normal Intestine Pancreatic NSCLC Ovarian Cancer GBM
Cancer
~50 kHz 150 kHz 150 kHz 200 kHz 200 kHz
© Novocure 2018 26transducer array placement
abdominal torso pelvic
array placement array placement array placement
© Novocure 2018 27addressing large market segments with
significant unmet medical needs
BRAIN NON-SMALL CELL PANCREATIC OVARIAN
MESOTHELIOMA
METASTASES LUNG CANCER CANCER CANCER
258,000 659,000 223,000 100,000 13,000
CASES DIAGNOSED CASES DIAGNOSED CASES DIAGNOSED CASES DIAGNOSED CASES DIAGNOSED
ANNUALLY IN TARGET ANNUALLY IN ANNUALLY IN ANNUALLY IN ANNUALLY IN
MARKETS1 TARGET MARKETS3-5 TARGET MARKETS3-5 TARGET MARKETS3-5 TARGET MARKETS3,6-7
~25% 24% 8% 47% 9%
OF NSCLC PATIENTS FIVE YEAR SURVIVAL3 FIVE YEAR SURVIVAL3 FIVE YEAR SURVIVAL3 FIVE YEAR SURVIVAL3
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 28FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA
phase 2 pilot STELLAR trial
A prospective, open label, single-arm, non-randomized, multicenter study testing safety and preliminary efficacy of
TTFields at 150 kHz in combination 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
• Endpoints:
o Primary endpoint — overall survival (OS)
o Secondary endpoints — progression free survival (PFS), response rate, treatment-emergent toxicity
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 May]. Available from: https://clinicaltrials.gov/ct2/show/NCT02397928. NLM Identifier: NCT02397928
© Novocure 2018 29FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA
phase 2 pilot STELLAR trial interim results
TTFIELDS WITH
PEMETREXED AND PEMETREXED AND
CISPLATIN OR CISPLATIN-ALONE
EFFICACY ENDPOINTS CARBOPLATIN 1 HISTORICAL RESULTS 2
Median PFS 7.3 months 5.7 months
Median OS Not yet reached 12.1 months
One-year survival rate 79.7% 50.3%
• Interim data for the first 42 patients, with average follow-up of 11.5 months, presented at IASLC 2016
• Final top-line results, announced April 2018, exceeded interim analysis for all efficacy endpoints
o Anticipate presentation of final results at a medical conference in 2H 2018
o Plan to submit Humanitarian Device Exemption application to the FDA in 2H 2018
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 May]. 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
© Novocure 2018 30FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA
phase 2 pilot STELLAR trial interim results
PROGRESSION-FREE SURVIVAL (N=42)1 OVERALL SURVIVAL (N=42) 1
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 May]. 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
© Novocure 2018 31BRAIN METASTASES FROM NON-SMALL CELL LUNG CANCER
METIS phase 3 pivotal trial initiated in 2016
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
randomization 1:1
stereotactic
ttfields MRI q2m until progression
radiosurgery
screening and baseline
evaluation
stereotactic
supportive care MRI q2m until progression
radiosurgery
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 May]. Available from: https://clinicaltrials.gov/ct2/show/NCT02831959. NLM Identifier: NCT02831959
© Novocure 2018 32SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER
phase 2 pilot EF-15 trial
A prospective, open label, single-arm, non-randomized, multicenter study testing safety and preliminary efficacy of
TTFields at 150 kHz in combination 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
TTFIELDS WITH PEMETREXED-ALONE
EFFICACY ENDPOINTS PEMETREXED 1 HISTORICAL RESULTS 2
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, 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 May]. 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
© Novocure 2018 33SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER
LUNAR phase 3 pivotal trial initiated in 2017
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 –
o OS of TTFields + docetaxel vs docetaxel alone (superiority)
o OS of TTFields + immune checkpoint inhibitors vs immune checkpoint inhibitors alone (superiority)
o OS of TTFields + docetaxel vs immune checkpoint inhibitors alone (non-inferiority)
ttfields + immune three post-
randomization
CT q6w until survival
checkpoint progression
progression follow up
progression on or screening and inhibitor/docetaxel follow-up visits
1:1
after platinum- baseline
based therapy evaluation three post-
immune checkpoint CT q6w until survival
progression
inhibitor/docetaxel progression follow up
follow-up visits
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 May]. Available from: https://clinicaltrials.gov/ct2/show/NCT02973789. NLM Identifier: NCT02973789
© Novocure 2018 34LOCALLY ADVANCED AND METASTATIC PANCREATIC CANCER
phase 2 pilot PANOVA trial
A prospective, open label, single-arm, non-randomized, multicenter study testing feasibility, safety and preliminary
efficacy of TTFields at 150 kHz in combination 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
TTFIELDS WITH NAB-PACLITAXEL +
TTFIELDS WITH GEMCITABINE-ALONE NAB-PACLITAXEL GEMCITABINE
EFFICACY ENDPOINTS GEMCITABINE 1 HISTORICAL RESULTS 2 + GEMCITABINE 3 HISTORICAL RESULTS 2
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, 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 May]. 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.
© Novocure 2018 35LOCALLY ADVANCED PANCREATIC CANCER
PANOVA 3 pivotal trial initiated in 2017
A prospective, randomized controlled, multicenter trial testing efficacy and safety of TTFields at 150 kHz in
combination 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
randomization 1:1
ttfields + nab-paclitaxel CT q8w until second line
survival follow up
+ gemcitabine progression chemotherapy
screening and baseline
evaluation
nab-paclitaxel + CT q8w until second line
survival follow up
gemcitabine progression chemotherapy
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 May]. Available from: https://clinicaltrials.gov/ct2/show/NCT03377491. NLM Identifier: NCT03377491
© Novocure 2018 36RECURRENT OVARIAN CANCER
phase 2 pilot INNOVATE trial
A prospective, open label, single-arm, non-randomized, multicenter study testing feasibility, safety, toxicity and
preliminary efficacy of TTFields at 200 kHz in combination 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
TTFIELDS PACLITAXEL-ALONE
EFFICACY ENDPOINTS WITH PACLITAXEL 1 HISTORICAL RESULTS 2
Median PFS 8.9 months 3.9 months*
Median OS Not yet reached 13.2 months
One-year survival rate 61%
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 May]. 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
© Novocure 2018 37You can also read
