ESMO 2022: Amgen, Regeneron, GRAIL and More Provide Updates

Cancer Research

Monday’s ESMO 2022 update brings news of a robust Keytruda/Padcev combination, positive data from Regeneron regarding Libtayo in cutaneous squamous cell carcinoma (CSCC), updates on Amgen's Lumakras trial and hopeful news from an early detection cancer test from GRAIL.

Amgen's Lumakras and Vectibix Effective Against CRC

Data from Amgen's Phase Ib CodeBreaK 101 study showed Lumakras (sotorasib), along with Vectibix (panitumumab), is safe and effective in patients with KRAS G12C-mutated colorectal cancer (CRC), the company announced. 

Vectibix is Amgen's monoclonal anti-epidermal growth factor receptor (anti-EGFR) antibody. The objective response rate (ORR) in the trial was 30%, which is significant, as David M. Reese, M.D., executive vice president of Research and Development at Amgen, stated that for this patient population, treatment response rates can be as low as 2%.

The data was presented during an oral session on Monday at the European Society for Medical Oncology (ESMO) Annual Meeting in Paris, France.

As a result of this positive data, Reese said Amgen will "continue to focus on combination approaches in colorectal cancer, including advancing CodeBreaK 300, the Phase III LUMAKRAS plus Vectibix trial in the chemotherapy-refractory patient population."

Astellas, Seagen and Merck Score in Urothelial Cancer

Astellas and Seagen’s Padcev (enfortumab vedotin-ejfv) in combination with Merck’s Keytruda in metastatic urothelial cancer (Ia/mUC) demonstrated a 64.5% confirmed objective response rate (ORR), the companies reported Monday.

The Phase Ib/II trial cohort K met the primary endpoint. Of the participants assessed, 10.5% achieved a complete response and 53.9% demonstrated a partial response. The median duration of response (DOR) per BICR was not reached.

In a monotherapy arm assessing Padcev monotherapy as first-line treatment for the same indication, data demonstrated a 45.2% confirmed ORR. The monotherapy arm was not designed to be compared to the combination arm.

Jonathan E. Rosenberg, M.D., chief of genitourinary medical oncology service, division of solid tumor oncology at Memorial Sloan Kettering and Cohort K primary investigator, said the results “support the ongoing investigation of enfortumab vedotin and pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer.”

Libtayo Combo Appears Promising in Neoadjuvant CSCC

Among 16 presentations at ESMO, Regeneron  announced positive clinical data from a combination therapy of Libtayo (cemiplimab) as neoadjuvant monotherapy in stage II to IV resectable CSCC.

The data, from the primary analysis of a confirmatory Phase II trial, was also published in the New England Journal of Medicine.

In the Phase II trial, 79 patients received up to four fixed doses of Libtayo every three weeks before surgery. 62 received all four doses and 70 underwent surgery. Of these participants, 63.3% had a combined pathologic response rate, with 50.6% achieving the primary endpoint of complete pathologic response and 12.7% demonstrating a major pathologic response by independent pathologic review.

There was a 68% objective response rate (ORR) with 5 complete responses and 49 partial responses per local imaging review.

“This is exactly what our broad pipeline is trying to do,” using a variety of approaches to turn “cold tumors” into “hot tumors,” David Weinreich, M.D., EVP, global clinical development at Regeneron, said in a Monday webcast.

GRAIL’s Galleri More than Doubles Cancers Detected

GRAIL’s Galleri multi-cancer early detection (MCED) screening blood test added to standard of care screening more than doubled the number of cancers detected compared to standard screening alone, the company announced Monday.

GRAIL’s Galleri assay “detected more cancers than all U.S. Preventive Services Task Force-recommended standard single cancer screenings combined,” Jeffrey Venstrom, M.D., chief medical officer at GRAIL, said in a statement. These included Stage I cancers of the liver, small intestine and uterus, and Stage II pancreatic, bone and oropharyngeal cancers.

“This is particularly notable given the PATHFINDER population was heavily screened with higher-than-average rates for mammography, colonoscopy and low-dose CT lung scans,” Venstrom added.

"We are far more likely to have a cancer we aren't being screened for with standard single screening tests, so we need to transition from only screening for individual cancers to also screening individuals for cancer," Josh Ofman, president at GRAIL, told BioSpace. "We are very pleased with the PATHFINDER  results. Adding GRAIL's multi-cancer early detection test to standard-of-care screening more than doubled the number of cancers diagnosed in the population studied compared with standard screening alone. In fact, 71% of the participants whose cancers were found with our MCED test were diagnosed with cancers that do not have routine screening."

Jiangsu Hengrui Reports “Significantly Prolonged OS” in uHCC

Jiangsu Hengrui Pharmaceuticals Co.reported that camrelizumab, an anti-PD1 checkpoint inhibitor, combined with rivoceranib (apatinib), significantly prolonged OS and progression-free survival (PFS), with improved ORR versus sorafenib in first-line unresectable hepatocellular carcinoma (uHCC).

Median OS was 22.1 months compared to 15.2 months with sorafenib alone. The median PFS for the combination was 5.6 months compared to 3.7 months for standard of care sorafenib. And confirmed ORR for the combination was 25.4% compared to 5.9% for sorafenib.

Lyell Presents Trial Design FOR CAR T-cell Therapy

Lyell Immunopharma announced a poster of its first-in-human Phase I trial design for LYL797. The drug is an ROR1-targeted CAR T-cell therapy for the treatment of solid tumors. It is specifically targeting patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors.

LYL797 uses both Gen-R and Epi-R, Lyell’s novel reprogramming technologies engineered to overcome barriers to successful adoptive cell therapy, such as T-cell exhaustion and lack of durable stemness. The trial will evaluate the drug in patients with relapsed/refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC).

"We look forward to testing our technology platforms in the clinic, thus specifically addressing the question of exhaustion and durable stemness as barriers to successful cell therapy in solid tumors," Tina Albertson, M.D., Ph.D., Lyell’s chief medical officer, told BioSpace.

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