Scientists at the Institute of Cancer Research in London have discovered that melanoma cells spread by harnessing a gene normally involved in the development of the nervous system.
The U.S. FDA has proposed to down-classify optical diagnostic devices and electrical impedance spectrometers from class III to class II, but there was little support for such a change in the first day of a two-day advisory hearing. The panelists saw the risk of a false negative for melanoma as too high to allow such devices to go through the 510(k) program, and thus manufacturers of these devices may continue to be required to file PMAs, replete with costly studies and long timelines to approval.
The U.S. FDA reported a proposed down-classification for two device types intended for detection of melanoma, a move that would ease the premarket path for similar devices. The agency noted that it has received only one PMA application each for optical diagnostic devices and electrical impedance spectrometers, which suggests the agency sees these device types as suffering for want of interest on the part of device makers.
New data from the phase I study of Ultimovacs ASA’s lead candidate showed positive two-year overall survival data for the cancer vaccine. UV-1, combined with the checkpoint inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.) for treating malignant melanoma, demonstrated a 24-month survival rate of 73% in all 30 patients in the study.
Researchers have long known that the developmental regulator WNT5A plays a role in the dissemination of tumor cells. Now, investigators from Johns Hopkins University have discovered that its suppression plays a role in the growth of metastases after a period of dormancy as well.
Phase II melanoma data characterized by Iovance Biotherapeutics Inc. as positive failed to excite Wall Street, which took away 53.6% of the company’s share value (NASDAQ:IOVA), or $8.10, and pushed the closing price to $7.02 on May 27. The San Carlos, Calif.-based firm offered results from registrational cohort 4 (n=87) of the C-144-01 study testing lifileucel (LN-144, autologous tumor infiltrating lymphocytes) in advanced melanoma.
Regeneron Pharmaceuticals Inc. proposes to buy Checkmate Pharmaceuticals Inc. though an all-cash price of $10.50 per share for about $250 million. That’s pretty much on target with Checkmate’s April 19 closing share price (NASDAQ:CMPI) of $10.35, as the stock gained a staggering 326% on the day.
Bristol Myers Squibb Co.’s relatlimab will hit the market as the first U.S. FDA-approved LAG-3 inhibitor, cleared by the agency for use in a fixed-dose combination with Opdivo (nivolumab) to treat adult and pediatric patients with unresectable or metastatic melanoma. The approval, a day ahead of the March 19 FDA target date, adds another type of immune checkpoint inhibitor to the oncology arsenal, which already includes drugs targeting PD-1/PD-L1 and CTLA4.
Four years after Bristol Myers Squibb Co.’s (BMS) $1.85 billion investment in Nektar Therapeutics Inc., the pair’s collaboration has stumbled mightily with a phase III failure. A first analysis their melanoma study, PIVOT IO-001, showed it missed three primary endpoints. The study of interleukin-2-targeting NKTR-214 (bempegaldesleukin) combined with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated, unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival and objective response rate.
Oncorus Inc. offered initial safety, tolerability and immune activation and clinical response data from its ongoing phase I trial with ONCR-177 at the Society for Immunotherapy of Cancer (SITC) meeting. In the fully enrolled and completed surface lesion, dose-escalation part of the study, single-agent ONCR-177, an oncolytic herpes simplex virus for intratumoral injection, proved well-tolerated with no dose-limiting toxicities.
