Oncology

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as Single Agent After Surgery Reduced Risk of Death by More Than One-Third (34%) Versus Neoadjuvant Chemotherapy in High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)

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Sunday, September 15, 2024
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The safety profile of KEYTRUDA was consistent with that observed in previously reported studies with no new safety signals observed.

Key Points: 
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies with no new safety signals observed.
  • At this analysis, treatment-related adverse events (TRAEs) were examined in the neoadjuvant phase, the adjuvant phase and the combined phases.
  • TRAEs led to death in 0.5% of patients receiving the KEYTRUDA regimen (n=4) and 0.3% of patients receiving the chemotherapy-placebo regimen (n=1).
  • Immune-mediated AEs led to death in 0.3% of patients receiving the KEYTRUDA regimen (n=2) and no patients receiving the chemotherapy-placebo regimen.

IMFINZI® (durvalumab) perioperative regimen reduced the risk of recurrence by 32% and the risk of death by 25% vs. neoadjuvant chemotherapy alone in muscle-invasive bladder cancer in the NIAGARA Phase III trial

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Sunday, September 15, 2024
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Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.

Replimune Presents Primary Analysis Data from IGNYTE Clinical Trial of RP1 Combined with Nivolumab in Anti-PD1 Failed Melanoma at European Society for Medical Oncology (ESMO) Congress 2024

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Sunday, September 15, 2024
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WOBURN, Mass., Sept. 15, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that data from the primary analysis of the IGNYTE clinical trial of RP1 combined with nivolumab were presented by Caroline Robert, M.D., Ph.D. of Gustave Roussy as a late breaking abstract during an oral session at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona.

Key Points: 
  • The primary analysis by blinded independent central review was triggered once all patients had been followed for at least 12 months.
  • Median duration of response from response initiation was 21.6 months and media duration of response from treatment initiation was 27.6 months.
  • At the time of the analysis, 85% of responses were ongoing more than a year from starting treatment.
  • While median overall survival has not been reached, one-, two- and three-year survival rates were 75.3%, 63.3% and 54.8% respectively.

DS-9606 Shows Promising Preliminary Clinical Activity in Patients with Advanced Solid Tumors

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Sunday, September 15, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Fatigue, ADC, Periodic breathing, Weight loss, Science, Daiichi Sankyo, Abdominal pain, Pleural effusion, Patient, GCT, Breast, Safety, Diarrhea, Sarah Cannon Research Institute, Cough, Arthralgia, Anemia, Sinusitis, PBD, Constipation, Drug development, Nausea, Gonadotropin, Rash, Endometrial cancer, MD, Tumor antigen, Lung cancer, Vomiting, Fever, Ovary, CLDN6, NSCLC, Medical imaging

DS-9606 is an investigational CLDN6 directed, modified pyrrolobenzodiazepine (PBD) antibody drug conjugate (ADC) from Daiichi Sankyo’s (TSE: 4568) second antibody drug conjugate (ADC) platform.

Key Points: 
  • DS-9606 is an investigational CLDN6 directed, modified pyrrolobenzodiazepine (PBD) antibody drug conjugate (ADC) from Daiichi Sankyo’s (TSE: 4568) second antibody drug conjugate (ADC) platform.
  • Patients received a median of four prior therapies (range, 1- 9).
  • Grade 3 or higher TEAEs occurred in 30.2% of patients (n=16) and included anemia (3.8%), abdominal pain (3.8%), pleural effusion (3.8%), constipation (1.9%), vomiting (1.9%) and diarrhea (1.9%).
  • Twenty one of the 53 patients are still receiving treatment with DS-9606 as of data cutoff of June 14, 2024.

New Data Presented at ESMO 2024 Show that Veracyte’s Decipher Prostate Test Predicts Chemotherapy Benefit in Patients with Metastatic Prostate Cancer

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Sunday, September 15, 2024
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These findings support Veracyte’s plan to expand use of the Decipher Prostate test – currently widely used to guide care for localized prostate cancer – to patients with metastatic disease.

Key Points: 
  • These findings support Veracyte’s plan to expand use of the Decipher Prostate test – currently widely used to guide care for localized prostate cancer – to patients with metastatic disease.
  • “For patients with metastatic prostate cancer, adding the chemotherapy docetaxel to standard-of-care androgen deprivation therapy (ADT) can increase survival.
  • Notably, docetaxel was beneficial in patients with higher Decipher Prostate scores regardless of whether they had high- or low-volume prostate cancer.
  • “These new phase 3 data from the STAMPEDE trial now further prove the performance and utility of our test in patients with metastatic prostate cancer.

Ten-Year Data for Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Sustained Overall Survival Benefit Versus Ipilimumab in Advanced Melanoma

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Sunday, September 15, 2024
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Based on 10 years of follow-up, the data showed sustained improved survival outcomes for patients receiving KEYTRUDA as a single agent compared to ipilimumab in patients with advanced melanoma.

Key Points: 
  • Based on 10 years of follow-up, the data showed sustained improved survival outcomes for patients receiving KEYTRUDA as a single agent compared to ipilimumab in patients with advanced melanoma.
  • For patients with advanced melanoma, these long-term follow-up data showed the 10-year OS rate for KEYTRUDA was 34.0% versus 23.6% for ipilimumab.
  • KEYTRUDA demonstrated a sustained OS benefit, reducing the risk of death by 29% (HR=0.71 [95% CI, 0.60-0.85]).
  • KEYNOTE-006 (ClinicalTrials.gov, NCT01866319 ) was an open-label, randomized Phase 3 study comparing the efficacy and safety of KEYTRUDA versus ipilimumab in participants with advanced melanoma.

Scorpion Therapeutics Presents Initial Clinical Data From Its Phase 1/2 Trial of STX-478 Demonstrating Potentially Best-in-Class Mutant-Selective PI3Kα Inhibition for the Treatment of Advanced Solid Tumors at ESMO Congress 2024

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Sunday, September 15, 2024
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Initial Phase 1 monotherapy data for STX-478, an oral, once-daily, mutant-selective, allosteric PI3Kα inhibitor, demonstrated potentially best-in-class PI3Kα inhibition, with anti-tumor activity observed in multiple cancer types, including HR+/HER2- breast cancer (BC), gynecological tumors, and other solid tumors.

Key Points: 
  • Initial Phase 1 monotherapy data for STX-478, an oral, once-daily, mutant-selective, allosteric PI3Kα inhibitor, demonstrated potentially best-in-class PI3Kα inhibition, with anti-tumor activity observed in multiple cancer types, including HR+/HER2- breast cancer (BC), gynecological tumors, and other solid tumors.
  • “STX-478 demonstrates potent and potentially best-in-class PI3Kα pathway inhibition as established by our early, differentiated signals of monotherapy efficacy, which exceed benchmarks of other pathway inhibitors.
  • We also are encouraged by early safety data that demonstrates minimal evidence of wild-type PI3Kα-mediated toxicities, with no patients discontinuing STX-478 due to treatment-related adverse events.
  • Together, these results suggest that our highly-selective mutant PI3Kα inhibitor could overcome the limitations of currently available pathway inhibitors and, consequently, meaningfully improve clinical outcomes for patients with PI3Kα kinase or helical domain-mutated solid tumors.

Bristol Myers Squibb Presents Landmark 10-Year Follow-Up Data from CheckMate -067 Which Showed Continued Durable Long-Term Survival Benefit with Opdivo® plus Yervoy® in Advanced Melanoma

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Sunday, September 15, 2024
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Bristol Myers Squibb (NYSE: BMY) today announced 10-year follow-up data from CheckMate -067, a randomized, double-blind, Phase 3 clinical trial, which showed continued durable improvement in survival with first-line Opdivo® (nivolumab) plus Yervoy® (ipilimumab) therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced 10-year follow-up data from CheckMate -067, a randomized, double-blind, Phase 3 clinical trial, which showed continued durable improvement in survival with first-line Opdivo® (nivolumab) plus Yervoy® (ipilimumab) therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma.
  • “Just over a decade ago, an advanced melanoma diagnosis meant that you likely only had months to live.
  • The dual immunotherapy combination of Opdivo plus Yervoy has radically changed this outlook for many of these patients,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, melanoma and gastrointestinal and genitourinary cancers, Bristol Myers Squibb.
  • Bristol Myers Squibb thanks the patients and investigators who have participated in the CheckMate -067 clinical trial.

Exelixis Presents Final Overall Survival Results from Phase 3 CONTACT-02 Pivotal Study Evaluating Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Metastatic Castration-Resistant Prostate Cancer at ESMO 2024

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Sunday, September 15, 2024
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Exelixis, Inc. (Nasdaq: EXEL) today announced detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT.
  • These data are being presented today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: GU Tumours, Prostate at 2:45 p.m. CEST.
  • “I believe there is a critical need for novel agents with a new mechanism of action that are broadly accessible to patients and can delay disease progression.
  • At a median follow-up of 24.0 months, the final analysis of OS showed a numerical but not statistically significant improvement favoring cabozantinib in combination with atezolizumab (hazard ratio: 0.89; 95% confidence interval: 0.72-1.10; P=0.296).

Investigational Rinatabart Sesutecan (Rina-S) Shows Promising Anti-Tumor Activity as Single Agent in Heavily Pretreated Patients with Ovarian and Endometrial Cancers in Phase 1/2 Clinical Trial

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Sunday, September 15, 2024
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These results, and additional findings from the study, were presented at the European Society of Medical Oncology Congress 2024 (ESMO) in Barcelona, Spain.

Key Points: 
  • These results, and additional findings from the study, were presented at the European Society of Medical Oncology Congress 2024 (ESMO) in Barcelona, Spain.
  • Ninety-five percent of patients in the 120 mg/m2 group were identified as platinum-resistant ovarian cancer (PROC) as were 90.9% of patients in the 100 mg/m2 group.
  • In patients receiving Rina-S 100 mg/m2, results showed a confirmed ORR of 18.2% compared with 50.0% among patients receiving 120 mg/m2.
  • We are committed to evaluating the full potential utility of Rina-S in patients with ovarian, endometrial and other solid tumor cancers.”