ESMO News: AstraZeneca, Merck, Janssen, Amgen and More
The European Society for Medical Oncology (ESMO) Virtual Congress 2020 was this weekend, with numerous companies presenting clinical trial data and updates. Here’s a roundup of some of the big stories that came out of the meeting.
AstraZeneca and Merck announced final results from the Phase III PROfound trial demonstrating Lynparza showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to enzalutamide or abiraterone in metastatic castration-resistant prostate cancer (mCRPC) patients who have BRCA1/2 or ATM gene mutations. Patients had progressed on previous treatment with enzalutamide and/or abiraterone.
AstraZeneca also updated results from the PACIFIC Phase III trial of Imfinzi in unresectable NSCLC who had not progressed on concurrent chemoradiation therapy (CRT). The post-hoc analyses showed an estimated four-year OS rate of 49.6% for Imfinzi compared to 36.3% for placebo after CERT. Median OS was 47.5 months for Imfinzi compared to 29.1 for placebo.
Merck presented new data for three investigation drugs: data from cohort expansions of a Phase Ib trial of vibostolimab as a monotherapy and in combination with its checkpoint inhibitor Keytruda in metastatic non-small cell lung cancer; first-time Phase I data for MK-4830 in advanced solid tumors demonstrating acceptable safety profile and early signals of anti-tumor activity; late-breaking Phase II data for MK-6482 demonstrated anti-tumor responses in von Hippel-Lindau (VHL) disease patients with clear cell renal cell carcinoma (RCC) and other tumors. Fibostolimab is an anti-TIGIT therapy. MK-4830 is an antibody against immunoglobulin-like transcript 4 (ILT4). MK-6482 is an oral HIF-2alpha inhibitor.
Merck and Eisai presented new data from two trials under the LEAP clinical program evaluating Keytruda plus Eisai’s Lenvima in unresectable or advanced melanoma that had previously progressed on an anti-PD-1/PD-L1 therapy. Lenvima is an orally available multiple receptor TKI. In the Phase II LEAP-005 trial, the combination demonstrated an ORR of 9.7%-32/3% in previously treated patients with triple-negative breast cancer, ovarian cancer, gastric cancer, and colorectal cancer. In the LEAP-004 Phase II trial of Keytruda and Lenvima in unresectable or advanced melanoma that had progressed on an anti-PD-1/PD-L1 therapy within 12 weeks, at a June 10 data cutoff, the combination demonstrated an overall ORR by BICR of 21.4% with a CRR of 1.9% and a partial response rate of 19.4%.
Janssen Pharmaceutical of Johnson & Johnson announced interim results from the CHRYSALIS trial of amivantamab in combination with the third-generation EGFR tyrosine kinase inhibitor (TKI) lazertinib in non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations. Amivantamab is a fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET) mutations.
MD Anderson Cancer Center and Amgen reported Phase I trial results for patients with advanced solid tumors marked by KRAS G12C mutations treated with sotorasib (AMG 510). With patients with KRAS G12C-mutant advanced NSCLC, the therapy demonstrated a confirmed response rate of 32.2% and disease control rate of 88.1% across all dose levels. In patients with KRAS G12C-mutant colorectal cancer, response rate was 7.1% and disease control rate was 73.8%.
Merck and the European Organization for Research and Treatment of Cancer (EORTC) announced new and updated findings from the Phase III EORTC1325/KEYNOTE-054 trial of Keytruda as adjuvant therapy in resected, high-risk stage III melanoma. The data showed that with 3.5 years of follow-up, Keytruda hit the key secondary endpoint of distant metastasis-free survival (DMFS), decreasing the risk of distant metastasis or death by 40% compared to placebo, with 3.5-year DMFS rates of 65.3% and 49.4%, respectively.
Immunomedics announced data from the confirmatory Phase III ASCENT trial demonstrated that Trodelvy (Sacituzumab govitecan-hziy) significantly extended OS and improved ORR and clinical benefit rate (CBR) compared to treatment of choice (TPC) standard single-agent chemotherapy in brain metastases-negative patients with mTNBC who had received at least two previous therapies for metastatic disease. Trodelvy is an antibody-drug conjugate (ADC) directed against Trop-2.
Bristol Myers Squibb and Exelixis presented the first data from the pivotal Phase III CheckMate -9ER trial of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) demonstrated significant improvements across all efficacy endpoints, including OS in previously untreated advanced renal cell carcinoma (RCC). The combination reduced the risk of death by 40% compared to sunitinib.
Regeneron Pharmaceuticals and Sanofi presented positive results from the pivotal Phase II trial of PD-1 inhibitor Libtayo (cmiplimab) in patients with locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy. The ORR was 31% with a median follow-up of 15 months, including a 6% complete and 25% partial response rate.
Eli Lilly and Company announced Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25% compared to standard adjuvant ET alone for people with HR-/HER2- high-risk early breast cancer. The benefit was consistent across all pre-specified subgroups and was equivalent to a 3.5% difference between arms, 92.2% for Verzenio and 88.7% in the control arm.