LINEUP SHAM 69 SEATTLE 2017 UPDATE

The mAb's target, PD-L1, interacts with programmed death receptor 1 (PD-1), which negatively regulates T-cell receptor signaling and inhibits anti-tumor T-cell function. As of November 2016, atezolizumab was not approved in the EU, but a marketing authorization application was undergoing evaluation by the EMA. Atezolizumab, which targets programmed cell death ligand 1 (PD-L1), was subsequently approved by the FDA for non-small cell lung cancer in October 2016. The mAb received breakthrough therapy designation, priority review status and accelerated approval for this indication.

LINEUP SHAM 69 SEATTLE 2017 UPDATE

*See note added in proof for update through December 31, 2016.Ītezolizumab (Tecentriq®) was approved in the US for treatment of patients with locally advanced or metastatic urothelial carcinoma in March 2016. Positive results from these studies may enable submission of marketing applications in 2017 or 2018, or provide justification for additional studies. Of these, 5 mAbs are for cancer (durvalumab, JNJ-56022473, ublituximab, anetumab ravtansine, glembatumumab vedotin) and 15 mAbs are for non-cancer indications (caplacizumab, lanadelumab, roledumab, tralokinumab, risankizumab, SA237, emapalumab, suptavumab, erenumab, eptinezumab, fremanezumab, fasinumab, tanezumab, lampalizumab, brolucizumab). Other ‘antibodies to watch' in 2017 include 20 mAbs are undergoing evaluation in pivotal studies that have estimated primary completion dates in late 2016 or during 2017. Based on announcements of company plans for regulatory submissions and the estimated completion dates for late-stage clinical studies, and assuming the study results are positive, marketing applications for at least 6 antibody therapeutics (benralizumab, tildrakizumab, emicizumab, galcanezumab, ibalizumab, PRO-140) that are now being evaluated in late-stage clinical studies may be submitted during December 2016* or 2017. In 2017, first EU or US approvals may also be granted for at least nine mAbs (ocrelizumab, avelumab, Xilonix, inotuzumab ozogamicin, dupilumab, sirukumab, sarilumab, guselkumab, romosozumab) that are not yet approved in any country. Regulatory actions on marketing applications for brodalumab in the EU and US are not expected until 2017. Brodalumab, was granted a first approval in Japan in July 2016. As of December 1, 2016, 6 mAbs (atezolizumab, olaratumab, reslizumab, ixekizumab, bezlotoxumab, oblitoxaximab) had been granted first approvals during 2016 in either the EU or US. In the United States (US), a total of 6 and 9 mAbs were granted first approvals during 20, respectively all these products are also approved in the European Union (EU). Over 50 investigational monoclonal antibody (mAb) therapeutics are currently undergoing evaluation in late-stage clinical studies, which is expected to drive a trend toward first marketing approvals of at least 6–9 mAbs per year in the near-term.

Lineup sham 69 seattle 2017