The partners announced updated results from two clinical trials examining Padcev (enfortumab vedotin-ejfv) alone (EV-201 Cohort 2) and Padcev in combination with Keytruda (EV-103 Cohort A) in patients with locally advanced or metastatic urothelial cancer who are not able to receive cisplatin chemotherapy. The data will be presented at ASCO.
Dear customer, we are sorry but your browser doesn't support all necessary features for good site view. Please switch to one of the modern browsers (Chrome, Safari, Firefox).
Seagen and Astellas announced updated results from two trials on Padcev
Patients in Cohort 2 of EV-201 received prior treatment with an immunotherapy but had not received a platinum-containing chemotherapy in the locally advanced or metastatic setting and were ineligible for cisplatin chemotherapy. With a median follow-up of 16 months, 51 percent of patients who received Padcev had a confirmed objective response per blinded independent central review, with 22 percent of patients experiencing a CR. Median DOR was 13.8 months. Patients lived a median of 6.7 months without cancer progression and had a median OS of 16.1 months.
In the dose-escalation cohort and expansion Cohort A in EV-103, patients were treated with a combination of Padcev and Keytruda as a first-line treatment for locally advanced or metastatic disease. Participants were ineligible for cisplatin-based chemotherapy, had no prior systemic treatment for locally advanced or metastatic disease, and did not receive adjuvant/neoadjuvant platinum-based therapy within 12 months prior to enrollment. The primary outcome measure in this analysis was safety. With a median follow-up of 24.9 months, the longer-term analysis demonstrated a safety profile generally consistent with previous findings with no new safety signals observed. Results demonstrated an ORR of 73.3 percent per investigator assessment, with 15.6 percent of patients experiencing a CR. The median PFS was 12.3 months. With longer-term follow-up, the study showed a median DOR of 25.6 months and median OS of 26.1 months.
ImmunoGen announced mature data from FORWARD II of mirvetuximab soravtancine in OVCA
ImmunoGen announced mature data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings will be highlighted in an oral presentation at ASCO. The cohort enrolled 60 patients with a median age of 60 and a median number of 2 prior lines of therapy. In the overall patient population, objective responses were seen in 30 patients and the confirmed ORR was 50%, with a median duration of response of 9.7 months and median PFS of 8.3 months. In patients with high FRα expression (n=33), the confirmed ORR was 64%, mDOR was 11.8 months, and mPFS was 10.6 months. The adverse events observed with the doublet were manageable and consistent with the side effect profiles of each agent.
Early data of AstraZeneca-Daiichi ADC seem promising in TNBC
Early data in triple-negative breast cancer suggest that an antibody-drug conjugate from Daiichi Sankyo and AstraZeneca show positive signals. A presentation at ESMO Breast Cancer congress showed that datopotamab led to ORR of 43% among 21 evaluable patients with TNBC in Phase 1 TROPION-PanTumor01 trial. That study is evaluating the ADC to treat TNBC in a third-line setting among patients with a median of four prior treatments; the TROPION trial also includes cohorts with hormone receptor-positive BRCA and NSCLC. The partners said there were five confirmed complete or partial responses in the TROPION study’s TNBC cohort; four additional responses were awaiting confirmation, as of a Jan. 8 data cutoff. The disease control rate was 95%.
REGULATORY
Zynlonta added to NCCN Guidelines in oncology for B-cell lymphomas
ADC Therapeutics announced its Zynlonta (loncastuximab tesirine-lpyl) has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines in oncology for B-cell Lymphomas. Specifically, the NCCN Guidelines now include Zynlonta as a category 2A designation as a treatment option for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. On April 23, FDA granted accelerated approval to Zynlonta for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy. This indication was based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
