Pluvicto, Novartis' first licenced radioligand therapy for PSMA-positive mCRPC, will be the subject of a subgroup analysis.

Pluvicto (177Lu-PSMA-617) was the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC in March 2022. Pluvicto (177Lu-PSMA-617) is a combination of a targeting chemical (ligand) and a therapeutic radioisotope. The FDA granted approval based on the results of the pivotal Phase III VISION trial, which showed a statistically significant reduction in the risk of death in patients with pretreated PSMA-positive mCRPC who received Pluvicto plus standard of care; both alternate primary endpoints of overall survival and radiographic progression-free survival were met.

The business is presently concentrating on the subgroup analysis component of Pluvicto in mCRPC, which will be presented as an oral presentation at the ASCO 2022 Conference on June 5, 2022. 177Lu-PNT2002 (PNT2002), another radiopharmaceutical created by Point Biopharma, is a PSMA-targeted therapy for mCRPC that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope lutetium-177. The corporation disclosed academic research in order to jump right into a Phase III clinical trial. They're working on determining whether their treatment is better than the standard of care in mCRPC patients, with top-line data from the Phase III study expected in Q3 2023.

Abstract Number – 5016

Modra Pharmaceuticals will present Phase II data in patients with mCRPC on oral docetaxel plus ritonavir (ModraDoc006/r).

Modra Pharmaceuticals published positive results from its Phase IIb trial comparing its enhanced oral taxane treatment, ModraDoc006/r, to the standard-of-care, IV chemotherapy docetaxel, in patients with mCRPC in February 2022. In addition, a pivotal study for ModraDoc006/r in patients with mCRPC is now being developed.

The first-line treatment choices for metastatic CRPC are diverse, and decisions are chosen based on the patient's prior treatments, whether for nmCRPC or mHSPC. Patients who have received escalated ADT for mHSPC with abiraterone, enzalutamide, or apalutamide, for example, should get a different strategy for mCRPC; in that first-line context, docetaxel chemotherapy (intravenous) plus an ADT combination is commonly suggested.

In addition, the trial evaluating ModraDoc006/r given orally to improve mCRPC outcomes is still ongoing. This highlights the need of providing alternative therapeutic choices in first-line mCRPC therapy, which can help drive market expansion and provide an alternate treatment option for mCRPC patients.

Abstract Number – 5049

The results of a Phase Ib/II trial of sabizabulin in males with mCRPC who had progressed on an androgen receptor targeted drug will be presented by Veru Pharma.

Sabizaulbin is being tested in a Phase Ib/II trial in individuals with mCRPC who have progressed on an androgen receptor targeted drug. Veru Pharma will disclose the results of this Phase Ib/II study's final analysis. At the ASCO GU Cancers Symposium 2022 in February 2022, Veru presented updated clinical results from the positive Phase Ib/II study of sabizabulin (VERU-111) in 80 men with mCRPC who had progressed on at least one new androgen receptor-targeting therapy.

In this updated presentation, sabizabulin therapy was shown to have anticancer action that was both cytotoxic and cytostatic. The ORR was 20.7 percent for patients having detectable illness at baseline (n = 29). In patients with detectable illness at trial entry, the best clinical response (stable disease or objective tumour response) was 59 percent (17/29). This Phase Ib/II clinical trial backs up the theory.

Abstract Number – 5078

Bayer plans to present findings from the Phase III ARASENS trial following the approval of the NDA.

In May 2022, the US FDA accepted a supplemental new drug application (sNDA) for darolutamide in conjunction with docetaxel for mHSPC and awarded it Priority evaluation. The application is being submitted under the FDA's Oncology Center of Excellence's (OCE) Project Orbis programme, which provides a framework for the simultaneous filing and examination of cancer treatments by collaborating international health authorities. After mHSPC receives priority review, it would be fascinating to learn about the efficacy parameters.

Nubeqa (darolutamide) is previously licenced for non-metastatic prostate cancer and is now being studied in both CSPC and CRPC patients. Given Nubeqa's recent favourable efficacy results when combined with Docetaxel and ADT, the business is anticipated to press through with the regulatory submission.

CONCLUSION

In men in the United States, prostate cancer is the second largest cause of cancer-related death. Previously, most of the focus in the field of advanced prostate cancer was on therapeutic research and development for patients with CRPC, despite the fact that CSPC patients have a poor prognosis and low quality of life. However, in recent years, the field of mCSPC has expanded as firms such as Bayer have moved their focus to mCSPC, which is a less congested market than CRPC. Nubeqa's first segment in prostate cancer, nmCRPC, obtained FDA approval. Nubeqa will likely face tough competition from Erleada and Xtandi (in both nmCRPC and mCSPC), with Xtandi's patent scheduled to expire by the end of the year.

Moving on to the already crowded CRPC market, we await the final results of Veru Pharma's Sabizabulin, which is slated to present its final Phase Ib/II data. However, we still need to see if Modra Pharma's oral docetaxel can replace IV docetaxel. Other companies like as Merck Sharp & Dohme (Keytruda/pembrolizumab), Pfizer (Talazoparib), Janssen (Niraparib), Clovis Oncology (Rubraca), Bristol-Myers Squibb (Opdivo), Exelixis (Cabozantinib), AstraZeneca (Capivasertib), and Genentech (Tecentriq) are researching new treatments.

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