Major clinical progress of global new tumor drugs | February 2021

According to incomplete statistics of public information, as of February 28, 2021, NextPharma has included a total of 8 recent major clinical advances in new drugs in the global oncology field.

Urothelial Carcinoma

1.

On February 8, BMS announced the results of the Phase III CheckMate-274 study, Opdivo (nivolumab) adjuvant treatment of patients with high recurrence risk of muscular invasive urothelial carcinoma after surgery, in all random populations and PD-L1 The primary study endpoint was reached in patients with expression ≥1%, which can significantly improve the disease-free survival (DFS) of patients.

2.

On February 11, Infinity announced the MARIO-275 phase 2 trial data of eganelisib.

Take-home message

Eganelisib is an oral, macrophage reprogramming drug candidate that specifically targets PI3Kγ

Eganelisib combined with nivolumab can increase immune activation and reduce immune suppression

Previously, the ORR of the phase 2 trial of eganelisib + atilizumab + paclitaxel albumin for the first-line treatment of triple-negative breast cancer reached 69.

3.

On February 12, Astellas and Seagen announced the EV-301 phase 3 trial data of enfortumab in the treatment of locally advanced or metastatic urothelial cancer.

Take-home message

Enfortumab is the first drug to target nectin-4, which is expressed in a variety of solid tumors, especially in bladder cancer

Enfortumab is also the first drug in clinical trials to prove effective for urothelial cancers that have failed platinum-based chemotherapy and PD1/PDL1 treatment

In December 2019, the FDA has accelerated the approval of enfortumab for locally advanced or metastatic urothelial cancer based on the phase 2 trial EV-201

4.

On February 16, ImmunityBio announced the data of the Phase 2/3 trial QUILT3.

Take-home message

N-803 is a new type of IL-15 receptor agonist with 30 times the activity of IL-15 and a longer half-life

N-803 can promote the expansion and activation of NK and CD8+ T cells, but does not affect immunosuppressive Treg cells

Previously, the FDA has granted N-803 Fast Track Qualification and Breakthrough Therapy Qualification for the treatment of this indication

Renal cell carcinoma

5.

On February 13, 2021, Exelixis announced the data of the Phase 2 trial SWOGS1500/PAPMET of cabozantinib in the treatment of metastatic papillary renal cell carcinoma.

6.

On February 13, Merck/Eisai presented an oral report on Keytruda (Pembrolizumab) + Lenvima (Levatinib) in the first-line treatment of advanced stage at the 2021 American Society of Clinical Oncology Symposium on Urogenital Tumors (ASCO GU 2021) Data from the key phase III CLEAR study (KEYNOTE-581) for renal cell carcinoma.

Prostate cancer

7.

On February 8, 2021, J&J announced the data of the Phase 3 trial ACIS (NCT02257736) for the first-line treatment of apatamide combined with abiraterone acetate in patients with metastatic castration-resistant prostate cancer.

The preliminary efficacy analysis showed that the median rPFS of the combined group was extended by 6 months compared with the control group (22.
6 vs 16.
6 months; HR=0.
69; p<0.
0001).
According to the latest analysis with a median follow-up of 54.
8 months, compared with the control group, the risk of radiological progression or death in the combination group was reduced by 30% (median rPFS: 24 months vs 16.
6 months; HR=0.
70).
In terms of secondary endpoints, there was no statistically significant difference between the combination group and the control group, including OS, time to initiate cytotoxic chemotherapy, time to initiate long-term opioid use, and time to pain progression.

Dalotamide vs apatamide vs enzalutamide (Source: NextPharma database)

Myelofibrosis

8.
The Phase 2 trial of Jacketinib in the treatment of intermediate/high-risk myelofibrosis achieved positive results

On February 23, 2021, Zejing Biological announced that its self-developed product Jacketinib hydrochloride tablets for the treatment of intermediate and high-risk myelofibrosis phase II clinical studies have achieved successful results.
The results of 104 subjects who have completed the 24-week follow-up show that the 24-week effective rate (ITT set) for the treatment of middle and high-risk myelofibrosis patients with 100 mg BID and 200 mg QD of Jacketinib tablets is 51.
9% and 30.
8%, respectively; The combined effective rate of the two groups was 41.
3%.
Jacketinib tablets can alleviate the constitutional symptoms of patients with myelofibrosis, and can significantly improve anemia, reduce blood transfusion dependence, improve the quality of life of patients, and have good tolerance and safety.
The detailed data of the trial will be announced in time at the relevant clinical hematology academic conference in 2021.

Jacketinib vs.
fedratinib vs.
Rucotinib (Source: NextPharma database)

Take-home message

Only two myelofibrosis targeted drugs, rucotinib and fedratinib, have been approved in the world, and rucotinib has been approved in China

Rucotinib vs.
placebo first-line treatment of medium/high-risk myelofibrosis phase 3 trial COMFORT-I, the proportion of patients whose spleen volume was reduced by ≥35% from baseline: 41.
9% vs.
0.
7%

Jacketinib is a deuterated JAK inhibitor, and a registered phase 3 trial comparing hydroxyurea in the treatment of medium and high-risk myelofibrosis is underway