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FDA granted accelerated approval to Tivdak in cervical cancer


29/11/2021 | 3 minuty čtení

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Astellas and Seagen win Japanese approval for Padcev in advanced urothelial cancer

Astellas and Seagen announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Padcev (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. The New Drug Application received priority review. The approval is primarily based on the global Phase 3 EV-301 clinical trial, which included sites in Japan. The trial evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. Median overall survival was 12.9 vs. 9 months.

Genmab and Seagen announced accelerated approval for Tivdak in cervical cancer

Genmab and Seagen announced that FDA has granted accelerated approval to Tivdak (tisotumab vedotin-tftv), the first and only approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

In the innovaTV 204 clinical trial, Tivdak was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Results from the trial showed a 24 % confirmed ORR. The median duration of response was 8.3 months. The therapy has a black box warning describing risks of ocular toxicity.


Positive data for Enhertu in gastric cancer, breast cancer and NSCLC

AZ and Daiichi presented positive results from Enhertu trials at ESMO. In the primary analysis of DESTINY-Gastric02, the first trial of Enhertu in patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma, Enhertu (6.4 mg/kg) demonstrated a confirmed ORR of 38%. Three (3.8%) complete responses (CR) and 27 (34.2%) partial responses (PR) were observed in patients treated with Enhertu. At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1.

After 15.5 and 13.9 months of follow-up in the Enhertu and T-DM1 arms respectively, the median PFS for patients treated with Enhertu was not reached compared to 6.8 months for T-DM1. Primary results from the HER2m cohort (cohort 2) of DESTINY-Lung01 in previously treated HER2m NSCLC demonstrated a confirmed objective response rate (ORR) of 54.9% in patients treated with Enhertu (6.4 mg/kg) as assessed by independent central review (ICR). One (1.1%) complete response (CR) and 49 (53.8%) partial responses (PR) were observed.

Clinical trial explores new FRα-targeting ADC for platinum-resistant ovarian cancer

The advances observed with STRO-002 include a Fast Track designation granted by the FDA in August 2021 for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior lines of systemic therapy. This announcement came shortly after early signals of efficacy were shown in 34 patients treated in a phase 1 clinical trial (NCT03748186) with STRO-002 at 2.9 mg/kg or higher. In 31 evaluable patients, treatment with STRO-002 led to responses in 10 patients, including 1 complete response and 9 partial responses (PRs). At the time of data cutoff, there were also 6 patients with unconfirmed PRs. The disease control rate was 74%.

STRO-002 also showed early signs of tolerability in the phase 1 study. Grade 1 or 2 treatment-emergent adverse events (TEAEs) occurred in 86% of patients. No ocular toxicity had occurred by the data cutoff date, but prophylactic corticosteroid eye drops had been administered to patients. The most common grade 3/4 TEAE was neutropenia, which was reversible. Standard medication was also administered to the 15.4% of patients who experienced grade 3 arthralgia and the 7.7% who experienced neuropathy.

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