Eli Lilly and Company recently presented data from two early-phase clinical trials from its ongoing immuno-oncology partnerships with Merck during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO).
The data originated from two randomized trials, KEYNOTE-021 and KEYNOTE-098, investigating Alimta (pemetrexed)-plus-carboplatin and Cyramza (ramucirumab) in combination with Merck’s Keytruda (pembrolizumab), in patients with non-small cell lung cancer (NSCLC).
Platinum-based chemotherapy is the standard of care for treatment-naive NSCLC patients without an activating EGFR mutation or ALK gene rearrangement. Preliminary data from the Phase 1/2 KEYNOTE-021 study suggested manageable toxicity and encouraging efficacy of platinum-doublet chemotherapy plus pembrolizumab, an anti–PD-1 monoclonal antibody, in treatment-naive patients with NSCLC.
KEYNOTE-098 evaluated the safety and preliminary efficacy of the combination of ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or transitional cell carcinoma of the urothelium.
The primary safety and preliminary efficacy results recently presented at ASCO were from the study cohort C, involving 27 NSCLC patients who received treatment after prior therapy (ramucirumab 10 mg/kg plus pembrolizumab 200 mg every three weeks).
The data showed that most NSCLC patients (20 out of 25) had a decrease in target lesions; this group of patients spanned the spectrum of PD-L1 status, from negative (40 percent) and not reported (25 percent) to weak-positive (5 percent) and strong-positive (30 percent). Moreover, subjects were also found to achieve an overall response rate (ORR) of 26 percent, with one complete response and six partial responses to ramucirumab-pembrolizumab therapy.
“These early data from the combinations of Alimta and Keytruda in front-line nonsquamous NSCLC, and Cyramza and Keytruda in later lines of NSCLC are encouraging,” Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology, said in a press release. “We eagerly await Phase 2 and Phase 3 data with the Alimta and Keytruda combinations and more mature data with the Cyramza and Keytruda combination in NSCLC, gastric, and bladder cancers, to better understand the role of immuno-oncology combinations in improving patient outcomes in these settings.”
“These data also reflect the progress that Lilly is making in its oncology R&D strategy to develop cancer treatments across three key areas of disease modification: tumor cell signaling, tumor micro-environment, and immuno-oncology,” Gaynor added. “This approach allows for testing of combinations of internally derived agents to address tumor heterogeneity and drug resistance.”
“We are pleased that these combination regimens are showing response rates in hard-to-treat tumor types across a range of treatment settings,” said Eric Rubin, M.D., vice president and therapeutic area head, oncology early-stage development at Merck Research Laboratories. “We believe combination regimens will play a key role in expanding the benefit of immuno-oncology to more patients, and look forward to working with Lilly to further explore these important combinations.”
