PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:

      The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in
      vitro and in vivo NSCLC pre-clinical models both as a single modality treatment and in
      combination with chemotherapies and PD-1 inhibitors. TTFields have been demonstrated to act
      synergistically with taxanes and have been shown to be additive when combined with PD-1
      inhibitors. In addition, TTFields have shown to inhibit metastatic spread of malignant
      melanoma in in vivo experiment.

      In a pilot study, 42 patients with advanced NSCLC who had had tumor progression after at
      least one line of prior chemotherapy, received pemetrexed together with TTFields (150 kHz)
      applied to the chest and upper abdomen until disease progression (Pless M., et al., Lung
      Cancer 2011). The combination was well tolerated and the only device-related adverse event
      was mild to moderate contact dermatitis. Efficacy endpoints were remarkably high compared to
      historical data for pemetrexed alone.

      In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active
      chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active
      chemotherapy in extending survival, associated with minimal toxicity, good quality of life,
      and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a
      phase III trial of Optune® combined with maintenance temozolomide compared to maintenance
      temozolomide alone has shown that combined therapy led to a significant improvement in both
      progression free survival and overall survival in patients with newly diagnosed glioblastoma
      without the addition of high grade toxicity and without decline in quality of life (Stupp R.,
      et al., JAMA 2015).

      DESCRIPTION OF THE TRIAL:

      All patients included in this trial are patients with squamous or non-squamous, stage 4 NSCLC
      who had disease progression on or after receiving platinum based chemotherapy. In addition,
      all patients must meet all eligibility criteria.

      Eligible patients will be randomly assigned to one of two groups:

      Patients receive docetaxel or immune checkpoint inhibitor in combination with TTFields using
      the NovoTTF-100L System.

      Patients receive docetaxel or immune checkpoint inhibitor without TTFields. Patients will be
      randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both
      arms. If assigned to the NovoTTF-100L group, the patients will be treated continuously with
      the device until disease progression in the thorax and/or liver according to RECIST or
      irRECIST (Immune-Related Response Evaluation Criteria In Solid Tumors) (depending if the
      patient is receiving docetaxel or immune checkpoint inhibitor, respectively).

      On both arms, patients who have disease progression according to RECIST or irRECIST
      (depending if the patient is receiving docetaxel or immune checkpoint inhibitor,
      respectively) will switch to a third line treatment according to local practice.

      SCIENTIFIC BACKGROUND:

      Electric fields exert forces on electric charges similar to the way a magnet exerts forces on
      metallic particles within a magnetic field. These forces cause movement and rotation of
      electrically charged biological building blocks, much like the alignment of metallic
      particles seen along the lines of force radiating outwards from a magnet.

      Electric fields can also cause muscles to twitch and if strong enough may heat tissues.
      TTFields are alternating electric fields of low intensity. This means that they change their
      direction repetitively many times a second. Since they change direction very rapidly (150
      thousand times a second), they do not cause muscles to twitch, nor do they have any effects
      on other electrically activated tissues in the body (brain, nerves and heart). Since the
      intensities of TTFields in the body are very low, they do not cause heating.

      The breakthrough finding made by Novocure was that finely tuned alternating fields of very
      low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in
      the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are
      multiplying, TTFields cause electrically-charged cellular components of these cells to change
      their location within the dividing cell, disrupting their normal function and ultimately
      leading to cell death. In addition, cancer cells also contain miniature building blocks which
      act as tiny motors in moving essential parts of the cells from place to place. TTFields
      interfere with the normal orientation of these tiny motors related to other cellular
      components since they are electrically-charged as well. As a result of these two effects,
      tumor cell division is slowed, results in cellular death or reverses after continuous
      exposure to TTFields.

      Other cells in the body (normal healthy tissues) are affected much less than cancer cells
      since they multiply at a much slower rate if at all. In addition TTFields can be directed to
      a certain part of the body, leaving sensitive areas out of their reach. Finally, the
      frequency of TTFields applied to each type of cancer is specific and may not damage normally
      dividing cells in healthy tissues.

      In conclusion, TTFields hold the promise of serving as a brand new treatment for NSCLC with
      very few side effects.