Pipeline Report: November 2022 | Articles

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Nivolumab-Based Therapy Drives Durable Responses in Recurrent/Metastatic Cervical Cancer

November 30th 2022

Nivolumab alone or in combination with ipilimumab produced encouraging responses that were maintained over time in patients with recurrent or metastatic cervical cancer.

FDA Grants Fast Track Designation to Batiraxcept for Advanced or Metastatic Clear Cell RCC

November 30th 2022

The FDA has granted a fast track designation to batiraxcept for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology–based and VEGF TKI–based therapies, either in combination or sequentially.

NT-I7/Pembrolizumab Combo Shows Clinical Efficacy in MSS CRC and Pancreatic Cancer Without Liver Metastasis

November 30th 2022

The combination of NT-I7 and pembrolizumab showed significant clinical activity in checkpoint inhibitor–naïve, relapsed/refractory microsatellite stable colorectal cancer and pancreatic cancer without liver metastasis.

FDA Grants RMAT, Fast Track Designations to CB-010 in Relapsed/Refractory Non-Hodgkin Lymphoma

November 29th 2022

The FDA has granted CB-010 a regenerative medicine advanced therapy designation for relapsed/refractory large B-cell lymphoma and a fast track designation for relapsed/refractory B-cell non-Hodgkin lymphoma.

Cabozantinib/Atezolizumab Elicits Durable, Tolerable Clinical Activity in Advanced HNSCC

November 29th 2022

The combination of cabozantinib and atezolizumab generated rapid and durable responses in patients with advanced head and neck squamous cell carcinoma who received prior treatment with platinum-based chemotherapy.

ARRY-614 Plus Immune Checkpoint Inhibition Can Induce Durable Responses in Advanced Solid Tumors

November 28th 2022

The combination of the p38 MAPK inhibitor ARRY-614 plus nivolumab with or without ipilimumab was well tolerated and elicited disease control in high-risk, PD-(L)1–refractory patients with advanced solid tumors.

Camsirubicin Elicits Early Clinical Activity in Advanced Soft Tissue Sarcoma

November 18th 2022

Camsirubicin in combination with pegfilgrastim produced encouraging clinical activity and safety in patients with advanced soft tissue sarcoma.

FDA Grants Orphan Drug Designation to Vebreltinib for NSCLC With MET Aberrations

November 17th 2022

The FDA has granted an orphan drug designation to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET genomic tumor aberrations.

FDA Grants Orphan Drug Designation to AVS100 for Stage IIB-IV Melanoma

November 17th 2022

The FDA has granted an orphan drug designation to the highly specific HDAC6 inhibitor AVS100 for the treatment of patients with stage IIB to IV melanoma.

Sotigalimab/Pembrolizumab Combo Continues to Show Clinical Activity in Frontline Melanoma

November 16th 2022

The combination of sotigalimab and pembrolizumab showed encouraging antitumor activity and was well tolerated in the frontline setting of patients with metastatic melanoma.

CYNK-101 Plus Avelumab Mediates ADCC Activity in Select PD-L1+ Solid Tumors

November 13th 2022

CYNK-101 demonstrated synergistic activity when used in combination with avelumab through antibody-dependent cellular cytotoxicity against PD-L1–positive non–small cell lung cancer, triple-negative breast cancer, and bladder cancer cell lines, according to preclinical data.

CTX130 Allogeneic CAR T-cell Therapy Shows Tolerability, Intriguing Activity in Advanced RCC

November 11th 2022

CTX130, an investigational allogeneic, CRISP/Cas9 gene-edited, anti-CD70 CAR T-cell therapy, was found to be safe with early signs of clinical activity in patients with advanced clear cell renal cell carcinoma, according to findings from the phase 1 COBALT-RCC trial.

Regorafenib Plus Ipilimumab and Nivolumab Shows Intriguing Activity in MSS mCRC

November 8th 2022

Regorafenib plus ipilimumab and nivolumab led to encouraging survival and responses in approximately half of patients with microsatellite stable, non–liver metastatic colorectal cancer who progressed on prior chemotherapy.

Nivolumab/Ipilimumab Plus CBM588 Generates Superior Efficacy in Metastatic RCC

November 7th 2022

The addition of CBM588 to the combination of nivolumab and ipilimumab produced superior response rates and a progression-free survival benefit vs nivolumab plus ipilimumab alone in previously untreated patients with metastatic renal cell carcinoma.

FDA Grants Breakthrough Therapy Designation to Elranatamab for Relapsed/Refractory Multiple Myeloma

November 3rd 2022

The FDA has granted a breakthrough therapy designation to elranatamab for the treatment of patients with relapsed/refractory multiple myeloma.

SRF388 Monotherapy Generates Responses in Locally Advanced/Metastatic NSCLC

November 3rd 2022

SRF388 elicited responses in pretreated patients with locally advanced or metastatic non–small cell lung cancer.

FDA Grants Orphan Drug Designation to OTX-2002 for Hepatocellular Carcinoma

November 2nd 2022

The FDA has granted an orphan drug designation to OTX-2002 for the treatment of patients with hepatocellular carcinoma.

Telisotuzumab Vedotin Plus Erlotinib Shows Encouraging Activity in Advanced c-Met+ NSCLC

November 1st 2022

Telisotuzumab vedotin in combination with erlotinib induced promising outcomes in patients with advanced, EGFR-mutated, c-MET-positive non–small cell lung cancer who were contraindicated for surgery or other approved therapies.

BCMA and CD3 T-cell–Engaging Bispecific Antibody Shows Promise in R/R Multiple Myeloma

November 1st 2022

ABBV-383 was effective and well tolerated at all administered doses in patients with relapsed/refractory multiple myeloma, according to safety and efficacy results from an ongoing first-in-human, phase 1 dose-escalation/-expansion study.