Editor's Note: This article was updated on May 01, 2018 at 3:15 PM PDT
Incyte Corp. (NASDAQ:INCY) reported 1Q18 earnings and said it is "downsizing" its program evaluating epacadostat, its indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor. The company plans to halt enrollment of six pivotal trials of epacadostat in combination with anti-PD-1 mAbs Keytruda pembrolizumab from Merck & Co. Inc (NYSE:MRK) or Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY).
The discontinued trials include four evaluating epacadostat plus Keytruda in squamous cell carcinoma of the head and neck (SCCHN), kidney cancer and bladder cancer, plus two evaluating epacadostat plus Opdivo in non-small cell lung cancer (NSCLC) and SCCHN.
Incyte will convert two additional combination trials -- the Phase III ECHO-305/KEYNOTE-654-01 and ECHO-306/KEYNOTE-715-02 trials -- into randomized Phase II trials. The trials are evaluating epacadostat-Keytruda combinations as first-line treatment for metastatic NSCLC.
The biotech said it will not begin a planned Phase III trial of epacadostat plus Imfinzi durvalumab, a mAb against PD-L1 from AstraZeneca plc (LSE:AZN; NYSE:AZN), to treat stage III NSCLC.
With the changes, Incyte cut its guidance for 2018 non-GAAP R&D expenses by $64 million to $1.013-$1.108 billion. Its 2018 product revenue guidance remains unchanged.
Incyte still intends to test epacadostat in combination with therapies outside of PD-1 and PD-L1 antagonists, including vaccines, chemotherapy, intratumoral adjuvants and CAR T cell therapies.
On April 6, Incyte and partner Merck reported that epacadostat plus Keytruda missed the primary endpoint of improving progression-free survival (PFS) vs. Keytruda alone in the Phase III ECHO-301/KEYNOTE-252 trial as first-line treatment of unresectable or metastatic melanoma (see BioCentury Extra, April 6).
Buysiders told BioCentury last month that a debate would emerge in the aftermath of the ECHO-301 data, with some believing a negative readout would call into question the merits of other proposed combination studies (see BioCentury, April 20).
BMS told BioCentury Tuesday it has halted three Phase III trials of Opdivo plus BMS-986205 to treat melanoma, SCCHN and NSCLC. The Phase I/II CA017-003 trial of BMS-986205 plus Opdivo or Opdivo and BMS’s Yervoy ipilimumab to treat advanced cancers, including melanoma or NSCLC, remains ongoing. Yervoy is a human mAb against CTLA4 (see BioCentury Extra, April 30).
For 1Q18, Incyte reported non-GAAP net loss per share of a penny on revenues of $382.3 million, compared with consensus estimates of a $0.03 profit on revenues of $390.2 million.
Incyte slipped $1.09 to $60.85 on Tuesday.
Merck, which also reported earnings before the market opened Tuesday, fell $0.89 to $57.98 on the day. On a conference call to discuss the earnings, President of Merck Research Laboratories Roger Perlmutter said the pharma has "scaled back" the epacadostat combination program, but is continuing some Phase II studies in lung cancer. "We'll look at these data from an immunologic perspective and try and understand exactly what happened there."
Merck reported 1Q18 EPS of $1.05 on revenues of $10 billion, in line with consensus estimates.